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GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety
This study is currently recruiting participants.
Verified by Accumetrics, Inc., June 2009
First Received: March 24, 2008   Last Updated: June 8, 2009   History of Changes
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

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 ]

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
Criteria

Inclusion Criteria:

  • Males or females aged 18 years or older.
  • 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.
  • Indication for the procedure may be stable angina (angina without a change in frequency or pattern for the 6 weeks before the procedure) or ischemia (ischemic findings on a stress test, i.e., stress EKG, stress ECHO, stress myocardial perfusion imaging), unstable angina without ST changes, or NSTE-ACS (unstable angina with ST changes, non-ST elevation MI).
  • 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.
  • A female patient is eligible to enter the study if she is (1) 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.
  • History of gastro-intestinal bleeding within 6 months.
  • 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.
  • Planned elective cardiac or non-cardiac surgery within 6 months.
  • Current or planned therapy with coumadin anticoagulation.
  • Current or planned therapy with other thienopyridine class of ADP receptor inhibitors (e.g., prasugrel)
  • Severe allergy to stainless steel, contrast dye, unfractionated heparin, low molecular weight heparin, 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.
  • Pre-procedure ("upstream") GPIIb/IIIa use (within 30 days for abciximab, or 5 days for tirofiban or eptifibitde),
  • Planned peri-procedural GPIIb/IIIa use.
  • 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 prior to randomization and those whom require a target vessel revascularization 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645918

Contacts
Contact: Judith Sheard GRAVITAS@scrippshealth.org

  Show 77 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 National Clinical Trials Identifier (NCT ID):
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

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:
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

ClinicalTrials.gov processed this record on February 08, 2010