Acute Coronary Syndrome Clinical Trial
— GRAVITASOfficial title:
GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety
Verified date | June 2011 |
Source | Accumetrics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after drug-eluting stent implantation.
Status | Completed |
Enrollment | 2800 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Males or females aged 18 years or older. - 2. Patients undergoing coronary angiography and possible PCI with planned use of at least one drug-eluting stent (DES), and without planned use of glycoprotein IIb/IIIa inhibitors. One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting, as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated for all lesions (DES + BMS + non stent). - Indication for the procedure may be stable angina or ischemia, unstable angina, non-ST elevation MI (NSTEMI), or ST elevation MI (STEMI). - Have the ability to understand the requirements of the study, including consent for use and disclosure of research-related health information. - Have the ability to comply with study procedures and protocol, including required study visits. - 6. A female patient is eligible to enter the study if she is (1) of child-bearing potential and not pregnant or nursing; (2) not of child-bearing potential (i.e., has had a hysterectomy, have both ovaries removed, has tubal ligation, or are post-menopausal, defined as 24 months without menses). Exclusion Criteria: Pre-PCI - PCI within previous 30 days. - Prior consent to participate in GRAVITAS and not randomized by IVRS. - History of gastro-intestinal bleeding within 6 months. - Major non-cardiac surgery within 6 weeks. - Ischemic stroke within 6 weeks. - Any history of hemorrhagic stroke or sub-arachnoid hemorrhage. - Other bleeding diathesis, or considered by investigator to be at high-risk for bleeding on long-term clopidogrel therapy. - Minor surgical procedures that require cessation of dual anti platelet therapy and result in significant bleeding are NOT eligible. - Current or planned therapy with coumadin anticoagulation. - Current or planned therapy with other thienopyridine class of ADP receptor inhibitors (e.g., prasugrel, ticlopidine), or the non-thienopyridine ticagrelor. - Severe allergy to stainless steel, contrast dye, unfractionated heparin, low molecular weight heparin, or bivalirudin that cannot be adequately pre-medicated. - Allergy to aspirin or clopidogrel. - Current enrollment in an investigational drug or device study that has not reached the time period of the primary endpoint. - Have received GPIIb/IIIa inhibitors eptifibatide or tirofiban within 24 hours before or during PCI or abciximab within 10 days before or during PCI. - Thrombocytopenia (defined as platelet count < 100 K). - Anemia (hematocrit < 30%). - Polycythemia (hematocrit > 52%). - Patients unwilling or unable to complete clinical follow-up for the duration of the study. Exclusion Criteria: Post-PCI - PCI with placement of at least one DES is not performed. - Planned staged PCI in the next 6 months post-procedure. - Unsuccessful PCI (post-procedure diameter stenosis >30% with less than TIMI-3 flow in any treated vessel). - Patients with in-hospital STEMI confirmed by ECG prior to randomization or those whom require a target vessel revascularization of the index lesion prior to randomization. - Patients with acute stent thrombosis before Accumetrics VerifyNow tests. - Administration of any GPIIb/IIIa during PCI procedure or prior to initial hospital discharge. - Failure to meet clopidogrel requirements - Major complication during or after PCI |
Country | Name | City | State |
---|---|---|---|
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | McMaster University | Hamilton | Ontario |
Canada | Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel-Dieu | Montréal | Quebec |
Canada | Hôpital du Sacré-Coeur de Montréal | Montréal | Quebec |
Canada | Montréal Heart Institute | Montréal | Quebec |
Canada | Royal Victoria Hospital | Montréal | Quebec |
Canada | York PCI Group | Newmarket | Ontario |
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Canada | Hôpital Laval | Québec | Quebec |
Canada | St. Michael's Hospital | Toronto | Ontario |
United States | AnMed Health | Anderson | South Carolina |
United States | St. Joseph's Research Institute | Atlanta | Georgia |
United States | Austin Heart P.A. | Austin | Texas |
United States | South Austin Hospital | Austin | Texas |
United States | Union Memorial Hospital | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Boston University Medical Center | Boston | Massachusetts |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | The Lahey Clinic | Burlington | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Jesse Brown VA Medical Center | Chicago | Illinois |
United States | University of Illinois Medical Center | Chicago | Illinois |
United States | The Lindner Clinical Trial Center | Cincinnati | Ohio |
United States | Clearwater Cardiovascular and Interventional Consultants | Clearwater | Florida |
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
United States | Baylor Heart and Vascular Hospital | Dallas | Texas |
United States | Danbury Hospital | Danbury | Connecticut |
United States | Geisinger Clinic - Cardiology | Danville | Pennsylvania |
United States | St. Mary's Duluth Clinic Health System | Duluth | Minnesota |
United States | Durham VA Medical Center | Durham | North Carolina |
United States | North Ohio Research, Ltd. | Elyria | Ohio |
United States | St. Vincent Health Center | Erie | Pennsylvania |
United States | Cleveland Cardiovascular Research Foundation | Fairview Park | Ohio |
United States | Plaza Medical Center of Fort Worth | Fort Worth | Texas |
United States | Carolina Cardiology Associates | High Point | North Carolina |
United States | The Methodist Hospital | Houston | Texas |
United States | St. Vincent Heart Center of Indiana/The Care Group LLC | Indianapolis | Indiana |
United States | University of Florida Health Science Center | Jacksonville | Florida |
United States | St. Luke's / Mid America Heart Institute | Kansas City | Missouri |
United States | Scripps Green Hospital | La Jolla | California |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Trinity Medical Center | Moline | Illinois |
United States | El Camino Hospital | Mountain View | California |
United States | Centennial Medical Center | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Lenox Hill Hospital | New York | New York |
United States | NY Presbyterian / Weill Cornell Medical Center | New York | New York |
United States | Christiana Care Hospital | Newark | Delaware |
United States | Oklahoma Cardiovascular Associates | Oklahoma City | Oklahoma |
United States | University of Oklahoma Health Science Center | Oklahoma City | Oklahoma |
United States | Cardiology Research Associates | Ormond Beach | Florida |
United States | Cardiac and Vascular Research Center of Northern Michigan | Petoskey | Michigan |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Hudson Valley Heart Center | Poughkeepsie | New York |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | The Miriam Hospital | Providence | Rhode Island |
United States | Wake Heart Research | Raleigh | North Carolina |
United States | Black Hills Clinical Research Center | Rapid City | South Dakota |
United States | Redmond Regional Medical Center | Rome | Georgia |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Sacramento Heart and Vascular Research Center | Sacramento | California |
United States | UC Davis Medical Center | Sacramento | California |
United States | University Hospital San Antonio (UTHSCSA) | San Antonio | Texas |
United States | Alvarado Hospital | San Diego | California |
United States | UCSD Medical Center | San Diego | California |
United States | San Francisco General Hospital | San Francisco | California |
United States | UCSF Moffitt-Long Hospital | San Francisco | California |
United States | Santa Barbara Cottage Hospital | Santa Barbara | California |
United States | Scottsdale Health Care - Osborn Campus | Scottsdale | Arizona |
United States | Scottsdale Health Care - Shea Campus | Scottsdale | Arizona |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Prairie Education & Research Cooperative | Springfield | Illinois |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Washington Adventist Hospital | Takoma Park | Maryland |
United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
United States | Tomball Regional Hospital | Tomball | Texas |
United States | Torrance Memorial Medical Center | Torrance | California |
United States | Washington Hospital Center | Washington | District of Columbia |
United States | Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | Wake Forest University | Winston-Salem | North Carolina |
United States | St. Joseph's Mercy Hospital | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Accumetrics, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard vs. tailored dosage | 6 months | ||
Secondary | Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard dosage vs. responders | 6 months |
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