Acute Coronary Syndrome Clinical Trial
— APPRAISE-2Official title:
Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome
Verified date | December 2015 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome
Status | Terminated |
Enrollment | 7484 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Acute coronary syndrome (ACS) - Clinically stable - Receiving standard of care for ACS Exclusion Criteria: - Severe hypertension - Active bleeding or high risk for major bleeding - Hemoglobin < 9 g/dL |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Argentina | Local Institution | Berazategui | Buenos Aires |
Argentina | Local Institution | Buenos Aires | |
Argentina | Local Institution | Buenos Aires | |
Argentina | Local Institution | Buenos Aires | |
Argentina | Local Institution | Buenos Aires | |
Argentina | Local Institution | Buenos Aires | |
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Poland | Local Institution | Slupsk | |
Poland | Local Institution | Szczecin | |
Poland | Local Institution | Tarnow | |
Poland | Local Institution | Torun | |
Poland | Local Institution | Warsaw | |
Poland | Local Institution | Warszawa | |
Poland | Local Institution | Warszawa | |
Poland | Local Institution | Warszawa | |
Poland | Local Institution | Wegrow | Mazowiekie |
Poland | Local Institution | Wloclawek | |
Poland | Local Institution | Zabrze | |
Poland | Local Institution | Zielona Gora | |
Puerto Rico | Local Institution | Cidra | |
Puerto Rico | Local Institution | San Juan | |
Romania | Local Institution | Arad | |
Romania | Local Institution | Baia Mare | |
Romania | Local Institution | Braila | |
Romania | Local Institution | Bucharest | |
Romania | Local Institution | Bucharest | |
Romania | Local Institution | Bucharest | |
Romania | Local Institution | Bucharest | |
Romania | Local Institution | Craiova | |
Romania | Local Institution | Oradea | |
Romania | Local Institution | Pitesti | |
Romania | Local Institution | Sibiu | |
Romania | Local Institution | Targu Mures | |
Romania | Local Institution | Timisoara | |
Russian Federation | Local Institution | Barnaul | |
Russian Federation | Local Institution | Chelyabinsk | |
Russian Federation | Local Institution | Ekaterinburg | |
Russian Federation | Local Institution | Ekaterinburg | |
Russian Federation | Local Institution | Kaluga | |
Russian Federation | Local Institution | Kazan | |
Russian Federation | Local Institution | Kemerovo | |
Russian Federation | Local Institution | Krasnoyarsk | |
Russian Federation | Local Institution | Krasnoyarsk | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow | |
Russian Federation | Local Institution | Moscow Reg. Zhekeznodorozhniy | |
Russian Federation | Local Institution | Nizhni Novgorod | |
Russian Federation | Local Institution | Nizhny Novgorod | |
Russian Federation | Local Institution | Nizhny Novgorod | |
Russian Federation | Local Institution | Novosibirsk | |
Russian Federation | Local Institution | Novosibirsk | |
Russian Federation | Local Institution | Novosibirsk | |
Russian Federation | Local Institution | Novosibirsk | |
Russian Federation | Local Institution | Odintsovo | |
Russian Federation | Local Institution | Penza | |
Russian Federation | Local Institution | Perm | |
Russian Federation | Local Institution | Rostov-On-Don | |
Russian Federation | Local Institution | Ryazan | |
Russian Federation | Local Institution | Saint Petersburg | |
Russian Federation | Local Institution | Saint Petersburg | |
Russian Federation | Local Institution | Saint Petersburg | |
Russian Federation | Local Institution | Saint Petersburg | |
Russian Federation | Local Institution | Saint Petersburg | |
Russian Federation | Local Institution | Saint-Petersburg | |
Russian Federation | Local Institution | Saint-Petersburg | |
Russian Federation | Local Institution | Saint-Petersburg | |
Russian Federation | Local Institution | Saint-Petersburg | |
Russian Federation | Local Institution | Saint-Petersburg | |
Russian Federation | Local Institution | Saratov | |
Russian Federation | Local Institution | Saratov | |
Russian Federation | Local Institution | St. Petersburg | |
Russian Federation | Local Institution | St. Petersburg | |
Russian Federation | Local Institution | St. Petersburg | |
Russian Federation | Local Institution | Tomsk | |
Russian Federation | Local Institution | Tver | |
Russian Federation | Local Institution | Tyumen | |
Russian Federation | Local Institution | Vasilievsky Island | |
Russian Federation | Local Institution | Voronezh | |
Russian Federation | Local Institution | Yaroslavl | |
Russian Federation | Local Institution | Yaroslavl | |
Russian Federation | Local Institution | Yaroslavl | |
Russian Federation | Local Institution | Yaroslavl | |
Russian Federation | Local Institution | Zhukovskiy | |
Singapore | Local Institution | Singapore | |
Singapore | Local Institution | Singapore | |
Slovakia | Local Institution | Banska Bystrica | |
Slovakia | Local Institution | Bratislava | |
Slovakia | Local Institution | Kosice | |
Slovakia | Local Institution | Kosice | |
Slovakia | Local Institution | Kosice | |
Slovakia | Local Institution | Kralovsky Chlmec | |
Slovakia | Local Institution | Liptovsky Hradok | |
Slovakia | Local Institution | Lucenec | |
Slovakia | Local Institution | Martin | |
Slovakia | Local Institution | Nitra | |
South Africa | Local Institution | Bellville | Western Cape |
South Africa | Local Institution | Bloemfontein | Free State |
South Africa | Local Institution | Bloemfontein | Free State |
South Africa | Local Institution | Centurion | Gauteng |
South Africa | Local Institution | Durban | Kwa Zulu Natal |
South Africa | Local Institution | Durban | Kwa Zulu Natal |
South Africa | Local Institution | Durban | Kwa Zulu Natal |
South Africa | Local Institution | Johannesburg | |
South Africa | Local Institution | Kuils River | Western Cape |
South Africa | Local Institution | Pinelands | Western Cape |
South Africa | Local Institution | Port Elizabeth | Eastern Cape |
South Africa | Local Institution | Port Elizabeth | Eastern Cape |
South Africa | Local Institution | Somerset West | Western Cape |
South Africa | Local Institution | Umhlanga | Kwa Zulu Natal |
South Africa | Local Institution | Wapadrand - Pretoria | Gauteng |
South Africa | Local Institution | Worcester | Western Cape |
Spain | Local Institution | Almeria | |
Spain | Local Institution | Barcelona | |
Spain | Local Institution | Barcelona | |
Spain | Local Institution | Caceres | |
Spain | Local Institution | El Ejido | |
Spain | Local Institution | Figueres | Gerona |
Spain | Local Institution | Granada | |
Spain | Local Institution | Lleida | |
Spain | Local Institution | Lugo | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | Madrid | |
Spain | Local Institution | Malaga | |
Spain | Local Institution | Oviedo | Asturas |
Spain | Local Institution | San Sebastian De Los Reyes | Madrid |
Spain | Local Institution | Santiago De Compostela | |
Spain | Local Institution | Sevilla | |
Spain | Local Institution | Tarragona | |
Spain | Local Institution | Torrevieja | |
Spain | Local Institution | Valencia | |
Spain | Local Institution | Valladolid | |
Spain | Local Institution | Villajoyosa | Alicante |
Spain | Local Institution | Zaragoza | |
Sweden | Local Institution | Eskilstuna | |
Sweden | Local Institution | Halmstad | |
Sweden | Local Institution | Helsingborg | |
Sweden | Local Institution | Karlskoga | |
Sweden | Local Institution | Karlstad | |
Sweden | Local Institution | Koping | |
Sweden | Local Institution | Lidkoping | |
Sweden | Local Institution | Molndal | |
Sweden | Local Institution | Skovde | |
Sweden | Local Institution | Stockholm | |
Sweden | Local Institution | Stockholm | |
Sweden | Local Institution | Uppsala | |
Sweden | Local Institution | Vaxjo | |
Switzerland | Local Institution | Geneve | |
Switzerland | Local Institution | Lugano | Ticino |
Switzerland | Local Institution | St Gallen | |
Switzerland | Local Institution | Zurich | |
Switzerland | Local Institution | Zurich | |
Turkey | Local Institution | Ankara | |
Turkey | Local Institution | Besevler | Ankara |
Turkey | Local Institution | Bornova | Izmir |
Turkey | Local Institution | Diyarbakir | |
Turkey | Local Institution | Isanbul | Haseki |
Turkey | Local Institution | Isparta | |
Turkey | Local Institution | Kirikkale | |
Turkey | Local Institution | Konya | |
Ukraine | Local Institution | Chernivtsy | |
Ukraine | Local Institution | Dnipropetrovsk | |
Ukraine | Local Institution | Dnipropetrovsk | |
Ukraine | Local Institution | Donetsk | |
Ukraine | Local Institution | Donetsk | |
Ukraine | Local Institution | Donetsk | |
Ukraine | Local Institution | Ivano-Frankivsk | |
Ukraine | Local Institution | Kharkiv | |
Ukraine | Local Institution | Kharkiv | |
Ukraine | Local Institution | Kharkiv | |
Ukraine | Local Institution | Kharkiv | |
Ukraine | Local Institution | Kharkiv | |
Ukraine | Local Institution | Kyiv | |
Ukraine | Local Institution | Kyiv | |
Ukraine | Local Institution | Kyiv | |
Ukraine | Local Institution | Kyiv | |
Ukraine | Local Institution | Lugansk | |
Ukraine | Local Institution | Lutsk | |
Ukraine | Local Institution | Lviv | |
Ukraine | Local Institution | Lviv | |
Ukraine | Local Institution | Mykolayiv | |
Ukraine | Local Institution | Odessa | |
Ukraine | Local Institution | Odessa | |
Ukraine | Local Institution | Simferopol | |
Ukraine | Local Institution | Vinnitsa | |
Ukraine | Local Institution | Zhaporizhzhya | |
United Kingdom | Local Institution | Ayr | Ayrshire |
United Kingdom | Local Institution | Basildon | Essex |
United Kingdom | Local Institution | Belfast | Antrim |
United Kingdom | Local Institution | Belfast | Armagh |
United Kingdom | Local Institution | Blackpool | Lancashire |
United Kingdom | Local Institution | Cambridge | Cambridgeshire |
United Kingdom | Local Institution | Chelmsford | Essex |
United Kingdom | Local Institution | Chesterfield | Derbyshire |
United Kingdom | Local Institution | Cottingham | East Yorkshire |
United Kingdom | Local Institution | Doncaster | South Yorkshire |
United Kingdom | Local Institution | Dumfries | Dumfriesshire |
United Kingdom | Local Institution | Harrow | Middlesex |
United Kingdom | Local Institution | Kilmarnock | Ayrshire |
United Kingdom | Local Institution | New Castle Upon Tyne | Tyne And Wear |
United Kingdom | Local Institution | Portadown | Armagh |
United Kingdom | Local Institution | Romford | Essex |
United Kingdom | Local Institution | Scunthorpe | Lincolnshire |
United Kingdom | Local Institution | Tunbridge Wells | Kent |
United Kingdom | Local Institution | Worksop | Nottinghamshire |
United States | Otfried N. Niedermaier, Md | Akron | Ohio |
United States | Phase Care, Llc | Alameda | California |
United States | Alexandria Cardiology Clinic | Alexandria | Louisiana |
United States | Clinical Research Network | Alexandria | Louisiana |
United States | Endeavor Medical Research, Plc | Alpena | Michigan |
United States | Orlando Heart Specialists | Altamonte Springs | Florida |
United States | Blair Medical Associates, Inc. | Altoona | Pennsylvania |
United States | Amarillo Heart Clinical Research Institute Inc. | Amarillo | Texas |
United States | Mcfarland Clinic Pc | Ames | Iowa |
United States | Cardiology Consultants Of Orange County | Anaheim | California |
United States | Anmed Health | Anderson | South Carolina |
United States | Carl Wilson Sofley, Jr., Md | Anderson | South Carolina |
United States | Local Institution | Annapolis | Maryland |
United States | Asheville Cardiology Associates | Asheville | North Carolina |
United States | Kentucky Heart & Vascular Physicians | Ashland | Kentucky |
United States | Cardiovascular Physicians Of North Atlanta | Atlanta | Georgia |
United States | Palm Beach Heart Institute, Llc | Atlantis | Florida |
United States | Medical College Of Georgia | Augusta | Georgia |
United States | Beaver Medical Group | Banning | California |
United States | City Cardiology Associates | Barberton | Ohio |
United States | Blue Stem Cardiology | Bartlesville | Oklahoma |
United States | Lowcountry Medical Group | Beaufort | South Carolina |
United States | St. Charles Health System, Inc. | Bend | Oregon |
United States | St. Lukes Cardiology Associates | Bethlehem | Pennsylvania |
United States | Uab Medical Center | Birmingham | Alabama |
United States | University Of Alabama At Birmingham | Birmingham | Alabama |
United States | Rocky Mountain Cardiology | Boulder | Colorado |
United States | Local Institution | Brick | New Jersey |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | Buffalo General Hospital | Buffalo | New York |
United States | Memorial Hospital Of Carbondale | Carbondale | Illinois |
United States | The University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina |
United States | The Chattanooga Heart Institute | Chattanooga | Tennessee |
United States | Bermisa Family Practice & Research Center | Chesapeake | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University Of Chicago Hospitals | Chicago | Illinois |
United States | Local Institution | Chula Vista | California |
United States | Cincinnati Veterans Affairs Medical Center | Cincinnati | Ohio |
United States | Ronald L. Walsh, Do | Clearwater | Florida |
United States | The Heart And Vascular Institute Of Florida | Clearwater | Florida |
United States | Columbia Cardiology | Columbia | South Carolina |
United States | Missouri Cardiovascular Specialists | Columbia | Missouri |
United States | Columbus Cardiology Associates Pc | Columbus | Georgia |
United States | Georgia Heart Specialists | Covington | Georgia |
United States | Cardiovascular Research Institute Of Dallas | Dallas | Texas |
United States | Dallas Va Medical Center | Dallas | Texas |
United States | Heart Consultants Of North Texas | Dallas | Texas |
United States | Zakhary, Bosh | Danville | Virginia |
United States | Cardiovascular Specialist Of South Florida | Davie | Florida |
United States | Atlanta Institute For Medical Research, Inc | Decatur | Georgia |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Local Institution | Detroit | Michigan |
United States | In-Quest Medical Research, Llc | Duluth | Georgia |
United States | Alta Pharmaceutical Research Center, Inc. | Dunwoody | Georgia |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Central Jersey Medical Research Center | Elizabeth | New Jersey |
United States | Elkhart Clinic, Llc | Elkhart | Indiana |
United States | North Georgia Medical Research | Ellijay | Georgia |
United States | Consultants In Cardiovascular Diseases, Inc. | Erie | Pennsylvania |
United States | Hamot Medical Center | Erie | Pennsylvania |
United States | Escondido Cardiology Associates, Inc. | Escondido | California |
United States | Fairfield Cardiac Cath Lab, Llc | Fairfield | Ohio |
United States | Local Institution | Fargo | North Dakota |
United States | Sparks Regional Medical Center | Fort Smith | Arkansas |
United States | T&R Clinic | Fort Worth | Texas |
United States | Texas Health Research & Education Institute | Fort Worth | Texas |
United States | David E. Perloff, Md | Ft. Lauderdale | Florida |
United States | Northeast Georgia Heart Cntr, Pc | Gainesville | Georgia |
United States | Genoa Medical Center | Genoa | Ohio |
United States | The Stern Cardiovascular Center, Pa | Germantown | Tennessee |
United States | Genesys Regional Medical Center | Grand Blanc | Michigan |
United States | East Carolina Heart Institute At East Carolina University | Greenville | North Carolina |
United States | Clinical Investigation Specialists, Inc | Gurnee | Illinois |
United States | Hamilton Cardiology Associates | Hamilton | New Jersey |
United States | St Margaret Mercy Healthcare Centers | Hammond | Indiana |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Local Institution | Hazard | Kentucky |
United States | William D. Bowden, D.O. | Healdsburg | California |
United States | Heart Care Associates P.C. | Hopewell | Virginia |
United States | Centex Research, Pineloch Medical Clinic | Houston | Texas |
United States | Heart Care Center | Houston | Texas |
United States | Med Tech, Inc. | Houston | Texas |
United States | Methodist Debakey Heart & Vascular Center | Houston | Texas |
United States | Northwest Houston Cardiology, Pa | Houston | Texas |
United States | California Heart Specialists, Inc. | Huntington Beach | California |
United States | Heart Center Research, Llc | Huntsville | Alabama |
United States | Krannertt Institute Of Cardiology | Indianapolis | Indiana |
United States | R. L.Roudebush Va Medical Center | Indianapolis | Indiana |
United States | The Care Group, Llc | Indianapolis | Indiana |
United States | Nature Coast Clinical Research | Inverness | Florida |
United States | Local Institution | Jackson | Mississippi |
United States | Research Associates Of Jackson | Jackson | Tennessee |
United States | University Of Mississippi Medical Center | Jackson | Mississippi |
United States | East Coast Institute For Research | Jacksonville | Florida |
United States | Jacksonville Center For Clinical Research | Jacksonville | Florida |
United States | Jacksonville Heart Center, Pa | Jacksonville | Florida |
United States | Gateway Cardiology. P.C | Jerseyville | Illinois |
United States | Mountain State Health Alliance | Johnson City | Tennessee |
United States | Richard M. Kastelic M.D. & Associates, P.C. | Johnstown | Pennsylvania |
United States | Nea Baptist Clinic | Jonesboro | Arkansas |
United States | Knoxville Heart Group | Knoxville | Tennessee |
United States | Caring Clinical Research Corporation | Laguna Hills | California |
United States | The Cardio Vascular Center P.A. | Lake Mary | Florida |
United States | Eisenstein, Isaac | Lakewood | California |
United States | The Heart Group | Lancaster | Pennsylvania |
United States | Thoracic And Cardiovascular Healthcare Foundation | Lansing | Michigan |
United States | Utah Cardiology P.C | Layton | Utah |
United States | Bryanlgh Heart Institute | Lincoln | Nebraska |
United States | Local Institution | Linden | New Jersey |
United States | South Denver Cardiology Associates Pc | Littleton | Colorado |
United States | Midwest Heart Foundation | Lombard | Illinois |
United States | Arvind J. Mehta, Md | Long Beach | California |
United States | Local Institution | Los Alamitos | California |
United States | Preciado Cardiology Incorporated | Los Angeles | California |
United States | Cardiovascular Associates, Psc | Louisville | Kentucky |
United States | Texas Cardiac Center | Lubbock | Texas |
United States | The Cardiology Group Centra. | Lynchburg | Virginia |
United States | Mercer University School Of Medicine | Macon | Georgia |
United States | Dean And St. Mary'S Outpatient Center | Madison | Wisconsin |
United States | Virginia Cardiolovascular Associates | Manassas | Virginia |
United States | Well Star Cardiovascular Medicine, Pc | Marietta | Georgia |
United States | Dr. Michael Sacher | Massapequa | New York |
United States | Alpha Medical Research, Llc | Melbourne | Florida |
United States | Melbourne Internal Medicine Associates (Mima) | Melbourne | Florida |
United States | Advanced Pharma Clinical Research | Miami | Florida |
United States | Glenn J. Barquet, Md | Miami | Florida |
United States | Miami Cardiology Clinical Research, L.L.C. | Miami | Florida |
United States | Mount Sinai Medical Center | Miami Beach | Florida |
United States | Middletown Cardiovascular Associates | Middletown | Ohio |
United States | Local Institution | Midlothian | Virginia |
United States | Wheaton Franciscan Healthcare St. Joseph | Milwaukee | Wisconsin |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | University Of Minnesota, Medical School | Minneapolis | Minnesota |
United States | Va Medical Center | Minneapolis | Minnesota |
United States | Local Institution | Moline | Illinois |
United States | Local Institution | Mt. Pleasant | Michigan |
United States | Medical Consultants, Pc | Muncie | Indiana |
United States | Access Clinical Trials | Nashville | Tennessee |
United States | Tulane University Hospital And Clinic | New Orleans | Louisiana |
United States | Alfieri Cardiology | Newark | Delaware |
United States | Sendara Cardiovasular Research Institute | Norfolk | Virginia |
United States | Illinois Heart & Lung Research | Normal | Illinois |
United States | Parkway Cardiology Associates, Pc | Oak Ridge | Tennessee |
United States | East Bay Physicians Medical Group | Oakland | California |
United States | Mediquest Research Group Inc. | Ocala | Florida |
United States | Ocala Research Institute, Inc | Ocala | Florida |
United States | Cor Clinical Research, Llc | Oklahoma City | Oklahoma |
United States | Oklahoma Cardiovascular Associates | Oklahoma City | Oklahoma |
United States | University Of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Alegent Health Clinic Heart & Vascular Specialists | Omaha | Nebraska |
United States | Heart Consultants | Omaha | Nebraska |
United States | St. Joseph Heritage Medical Group | Orange | California |
United States | Florida Heart Group | Orlando | Florida |
United States | Orlando Heart Center | Orlando | Florida |
United States | Midwest Cardiology Associates , P.C. | Overland Park | Kansas |
United States | Research Integrity, Llc | Owensboro | Kentucky |
United States | Palm Beach Gardens Research Center Llc | Palm Beach Gardens | Florida |
United States | Local Institution | Pembroke Pines | Florida |
United States | Cardiology Consultants | Pensacola | Florida |
United States | Heartcare Midwest | Peoria | Illinois |
United States | Drexel University College Of Medicine | Philadelphia | Pennsylvania |
United States | Penn Presbyterian Medical Center | Philadelphia | Pennsylvania |
United States | Pennsylvania Cardiology Associates | Philadelphia | Pennsylvania |
United States | North Phoenix Heart Center | Phoenix | Arizona |
United States | Advent Clinical Research Centers, Inc. | Pinellas Park | Florida |
United States | Va Pittsburgh Healthcare System | Pittsburgh | Pennsylvania |
United States | Cardio-Pulmonary Associates | Plantation | Florida |
United States | Avivo Clin Clinical Services | Port Orange | Florida |
United States | Portland Preventive Cardiology, L.L.C. | Portland | Oregon |
United States | Pottstown Medical Specialists, Inc | Pottstown | Pennsylvania |
United States | Hudson Valley Heart Center | Poughkeepsie | New York |
United States | The Miriam Hospital | Providence | Rhode Island |
United States | Wake Med Heart Center | Raleigh | North Carolina |
United States | Cardiology Assoicates, Pc/Black Hills Clinical Research Ctr | Rapid City | South Dakota |
United States | A.R.I. Clinical Trials, Inc. | Redondo Beach | California |
United States | Virgina Commonwealth Universitymedical Center | Richmond | Virginia |
United States | The Valley Hospital | Ridgewood | New Jersey |
United States | Southern Heart Research Institute, Llc | Riverdale | Georgia |
United States | Covenant Medical Center, Inc | Saginaw | Michigan |
United States | Delmarva Heart Research Foundation | Salisbury | Maryland |
United States | Peninsula Cardiology Associates, P.A. | Salisbury | Maryland |
United States | Central Cardiovascular Institute Of San Antonio | San Antonio | Texas |
United States | Jose A. Perez, M.D. | San Antonio | Texas |
United States | S.A.M. Clinical Research Center | San Antonio | Texas |
United States | Coastal Multi-Specialty Research | Santa Ana | California |
United States | Radiant Research, Inc | Santa Rosa | California |
United States | Heartcare Research | Sarasota | Florida |
United States | Local Institution | Scranton | Pennsylvania |
United States | Buxmont Cardiology Associates, Pc | Sellersville | Pennsylvania |
United States | Louisiana State University Health Sciences Center-Shreveport | Shreveport | Louisiana |
United States | Overton Brooks V.A.M.C. | Shreveport | Louisiana |
United States | North Central Heart Institute | Sioux Falls | South Dakota |
United States | Louisiana Heart Center | Slidell | Louisiana |
United States | Central New Jersey Cardiology | South Plainfield | New Jersey |
United States | Inland Cardiology Associates | Spokane | Washington |
United States | St. Augustine Cardiology Associates | St. Augustine | Florida |
United States | St Cloud Hospital | St. Cloud | Minnesota |
United States | Great Lakes Heart & Vascular Institute, Pc | St. Joseph | Michigan |
United States | Gateway Cardiology, P.C. | St. Louis | Missouri |
United States | Washington University School Of Medicine | St. Louis | Missouri |
United States | Sugarland Cardiology Associates | Sugarland | Texas |
United States | Franciscan Research Center | Tacoma | Washington |
United States | Dr Kiran C Patel Research Institute At Pepin Heart Hospital | Tampa | Florida |
United States | Scott&White Memorial Hospital | Temple | Texas |
United States | Toledo Cardiology Consultants | Toledo | Ohio |
United States | Northwest Heart Center | Tomball | Texas |
* Note: There are 1014 locations in all - only the first 1000 are shown. |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Duke Clinical Research Institute, Pfizer |
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants | Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). | Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years | No |
Primary | Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants | TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of = 5 grams per deciliter (g/dL), or =15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days. | From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years | Yes |
Secondary | Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants | Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010). | Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years | No |
Secondary | Event Rate of Stroke During the Intended Treatment Period - Randomized Participants | Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination). | Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years | No |
Secondary | Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants | MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (=0.04 s) Q waves in =2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice. | Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years | No |
Secondary | Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants | Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination. | Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years | No |
Secondary | Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants | Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination). | Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years | No |
Secondary | Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants | Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination). | Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years | No |
Secondary | Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants | Cause of death was determined by the principal condition that caused the death, not the immediate mode of death. CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination). |
Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years | No |
Secondary | Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants | ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days. | From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years | Yes |
Secondary | Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants | ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days. | From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years | Yes |
Secondary | Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants | Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days. | From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years | Yes |
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