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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety |
| Enrollment: | 2800 |
| Study Start Date: | June 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
"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.
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Drug: clopidogrel
oral, 75 mg daily for 6 months starting on day of randomization
Drug: clopidogrel
oral, 450 mg loading dose on day of randomization; 75 mg daily for 6 months starting on day of randomization
|
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Placebo Comparator: B
"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.
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Drug: clopidogrel
oral, 75 mg daily for 6 months starting on day of randomization
Drug: placebo
oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization
|
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Placebo Comparator: C
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.
|
Drug: clopidogrel
oral, 75 mg daily for 6 months starting on day of randomization
Drug: placebo
oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization
|
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
Show 82 Study Locations| Principal Investigator: | Matthew J Price, M.D. | Scripps Advanced Clnical Trials |
More Information
| Responsible Party: | Matthew J. Price, M.D., Scripps Advanced Clinical Trials |
| ClinicalTrials.gov Identifier: | NCT00645918 History of Changes |
| Other Study ID Numbers: | P95082 |
| Study First Received: | March 24, 2008 |
| Last Updated: | June 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Platelets Platelet Function Tests Clopidogrel Drug Eluting Stents Acute Coronary Syndrome |
Myocardial Ischemia Stent Thrombosis Heart Diseases Coronary Disease Arterial Occlusive Disease |
|
Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Thrombosis Acute Coronary Syndrome Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Coronary Disease Heart Diseases Embolism and Thrombosis Angina Pectoris Chest Pain Pain Signs and Symptoms |
Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents |