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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00831441
Other study ID # CV185-068
Secondary ID EUDRACT# 2008-00
Status Terminated
Phase Phase 3
First received January 28, 2009
Last updated December 18, 2015
Start date March 2009
Est. completion date March 2011

Study information

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

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Apixaban
Tablets, Oral, 5 mg, twice daily, until study end
Placebo
Tablets, Oral, 0 mg, twice daily, until study end

Locations

Country Name City State
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
Argentina Local Institution Capital Mendoza
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Argentina Local Institution Cordoba
Argentina Local Institution Cordoba
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Argentina Local Institution Cordoba
Argentina Local Institution Coronel Suarez Buenos Aires
Argentina Local Institution Corrientes
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Argentina Local Institution Haedo Buenos Aires
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Argentina Local Institution Posadas Misiones
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Argentina Local Institution Resistencia Chaco
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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.

Sponsors (3)

Lead Sponsor Collaborator
Bristol-Myers Squibb Duke Clinical Research Institute, Pfizer

Countries where clinical trial is conducted

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, 

Outcome

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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