GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety

This study has been completed.
Sponsor:
Information provided by:
Accumetrics, Inc.
ClinicalTrials.gov Identifier:
NCT00645918
First received: March 24, 2008
Last updated: June 15, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Accumetrics, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.
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
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.
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
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645918

  Show 82 Study Locations
Sponsors and Collaborators
Accumetrics, Inc.
Investigators
Principal Investigator: Matthew J Price, M.D. Scripps Advanced Clnical Trials
  More Information

No publications provided by Accumetrics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Accumetrics, Inc.:
Platelets
Platelet Function Tests
Clopidogrel
Drug Eluting Stents
Acute Coronary Syndrome
Myocardial Ischemia
Stent Thrombosis
Heart Diseases
Coronary Disease
Arterial Occlusive Disease

Additional relevant MeSH terms:
Acute Coronary Syndrome
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Syndrome
Thrombosis
Angina Pectoris
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Coronary Disease
Disease
Embolism and Thrombosis
Heart Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014