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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | "Tailored" clopidogrel regimen - an additional clopidogrel 600-mg loading dose (eight 75-mg tablets taken orally; daily 150 mg clopidogrel dose plus additional 450 mg clopidogrel) on the day of randomization and then 150-mg clopidogrel every day thereafter for 6 months. |
|
| B | Placebo Comparator | "Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets taken orally plus daily dose of one placebo tablet plus 75 mg clopidogrel) on the day of randomization followed by one placebo tablet plus 75 mg clopidogrel every day thereafter for 6 months. |
|
| C | Placebo Comparator | Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets taken orally plus daily dose of one placebo tablet plus 75 mg clopidogrel) on the day of randomization followed by one placebo tablet plus 75 mg clopidogrel every day thereafter for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | oral, 75 mg daily for 6 months starting on day of randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria: Pre-PCI
Exclusion Criteria: Post-PCI
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Price, M.D. | Scripps Advanced Clnical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Scottsdale Health Care - Osborn Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21875913 | Derived | Price MJ, Angiolillo DJ, Teirstein PS, Lillie E, Manoukian SV, Berger PB, Tanguay JF, Cannon CP, Topol EJ. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation. 2011 Sep 6;124(10):1132-7. doi: 10.1161/CIRCULATIONAHA.111.029165. Epub 2011 Aug 29. | |
| 21406646 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2014 | |
| Reset | Mar 12, 2014 |
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| placebo | Drug | oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization |
|
| clopidogrel | Drug | oral, 450 mg loading dose on day of randomization; 75 mg daily for 6 months starting on day of randomization |
|
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Scottsdale Health Care - Shea Campus | Scottsdale | Arizona | 85258 | United States |
| Scripps Green Hospital | La Jolla | California | 92037 | United States |
| El Camino Hospital | Mountain View | California | 94040 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Sacramento Heart and Vascular Research Center | Sacramento | California | 95825 | United States |
| UCSD Medical Center | San Diego | California | 92103 | United States |
| Alvarado Hospital | San Diego | California | 92120 | United States |
| San Francisco General Hospital | San Francisco | California | 94110 | United States |
| UCSF Moffitt-Long Hospital | San Francisco | California | 94143 | United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
| Torrance Memorial Medical Center | Torrance | California | 90503 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| Christiana Care Hospital | Newark | Delaware | 19718 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Clearwater Cardiovascular and Interventional Consultants | Clearwater | Florida | 33756 | United States |
| University of Florida Health Science Center | Jacksonville | Florida | 32209 | United States |
| Cardiology Research Associates | Ormond Beach | Florida | 32174 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| St. Joseph's Research Institute | Atlanta | Georgia | 30342 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| Jesse Brown VA Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois Medical Center | Chicago | Illinois | 60612 | United States |
| Trinity Medical Center | Moline | Illinois | 61265 | United States |
| Prairie Education & Research Cooperative | Springfield | Illinois | 62701 | United States |
| St. Vincent Heart Center of Indiana/The Care Group LLC | Indianapolis | Indiana | 46290 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70232 | United States |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| The Lahey Clinic | Burlington | Massachusetts | 01803 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Cardiac and Vascular Research Center of Northern Michigan | Petoskey | Michigan | 49770 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| St. Joseph's Mercy Hospital | Ypsilanti | Michigan | 48197 | United States |
| St. Mary's Duluth Clinic Health System | Duluth | Minnesota | 55805 | United States |
| St. Luke's / Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| NY Presbyterian / Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Hudson Valley Heart Center | Poughkeepsie | New York | 12601 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| Carolina Cardiology Associates | High Point | North Carolina | 27262 | United States |
| Wake Heart Research | Raleigh | North Carolina | 27610 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| North Ohio Research, Ltd. | Elyria | Ohio | 44035 | United States |
| Cleveland Cardiovascular Research Foundation | Fairview Park | Ohio | 44126 | United States |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Cardiovascular Associates | Oklahoma City | Oklahoma | 73120 | United States |
| Geisinger Clinic - Cardiology | Danville | Pennsylvania | 17822 | United States |
| St. Vincent Health Center | Erie | Pennsylvania | 16502 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| AnMed Health | Anderson | South Carolina | 29621 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Black Hills Clinical Research Center | Rapid City | South Dakota | 57701 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| South Austin Hospital | Austin | Texas | 78704 | United States |
| Austin Heart P.A. | Austin | Texas | 78756 | United States |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | United States |
| Plaza Medical Center of Fort Worth | Fort Worth | Texas | 76104 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University Hospital San Antonio (UTHSCSA) | San Antonio | Texas | 78229 | United States |
| Tomball Regional Hospital | Tomball | Texas | 77375 | United States |
| Royal Alexandra Hospital | Edmonton | Alberta | Canada |
| McMaster University | Hamilton | Ontario | Canada |
| York PCI Group | Newmarket | Ontario | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel-Dieu | Montreal | Quebec | Canada |
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | Canada |
| Montréal Heart Institute | Montreal | Quebec | Canada |
| Royal Victoria Hospital | Montreal | Quebec | Canada |
| Hôpital Laval | Québec | Quebec | Canada |
| Derived |
| Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290. |
| 19376306 | Derived | Price MJ, Berger PB, Angiolillo DJ, Teirstein PS, Tanguay JF, Kandzari DE, Cannon CP, Topol EJ. Evaluation of individualized clopidogrel therapy after drug-eluting stent implantation in patients with high residual platelet reactivity: design and rationale of the GRAVITAS trial. Am Heart J. 2009 May;157(5):818-24, 824.e1. doi: 10.1016/j.ahj.2009.02.012. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2014 | Mar 12, 2014 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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