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| Sponsor: | Accumetrics, Inc. |
|---|---|
| Information provided by: | Accumetrics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00645918 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Arteriosclerosis Acute Coronary Syndrome |
Drug: clopidogrel Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety |
| Estimated Enrollment: | 2783 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
"Tailored" clopidogrel regimen - an additional clopidogrel 450-mg loading dose (six 75-mg tablets taken orally) and then 150-mg every day for 6 months.
|
Drug: clopidogrel
oral, 75 mg daily for 6 months
Drug: clopidogrel
oral, 450 mg loading dose then 75 mg daily for 6 months
|
|
B: Placebo Comparator
"Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets) and then clopidogrel 75-mg and 1 placebo tablet every day for 6 months.
|
Drug: clopidogrel
oral, 75 mg daily for 6 months
Drug: placebo
oral, 6 pill loading dose then one pill daily for 6 months
|
|
C: Placebo Comparator
Responders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets) and then the standard clopidogrel regimen of 75-mg and 1 placebo tablet every day for 6 months.
|
Drug: clopidogrel
oral, 75 mg daily for 6 months
Drug: placebo
oral, 6 pill loading dose then one pill daily for 6 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria: Pre-PCI
Exclusion Criteria: Post-PCI
Contacts and Locations| Contact: Judith Sheard | GRAVITAS@scrippshealth.org |
Show 77 Study Locations| Principal Investigator: | Matthew J Price, M.D. | Scripps Advanced Clnical Trials |
More Information
| Responsible Party: | Scripps Advanced Clinical Trials ( Matthew J. Price, M.D. ) |
| Study ID Numbers: | P95082 |
| Study First Received: | March 24, 2008 |
| Last Updated: | June 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00645918 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Platelets Platelet Function Tests Clopidogrel Drug Eluting Stents Acute Coronary Syndrome |
Myocardial Ischemia Stent Thrombosis Heart Diseases Coronary Disease Arterial Occlusive Disease |
|
Arterial Occlusive Diseases Heart Diseases Disease Myocardial Ischemia Hematologic Agents Vascular Diseases Arteriosclerosis Pharmacologic Actions Thrombosis Coronary Disease |
Embolism and Thrombosis Pathologic Processes Therapeutic Uses Clopidogrel Syndrome Acute Coronary Syndrome Platelet Aggregation Inhibitors Cardiovascular Diseases Coronary Artery Disease |