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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Scottsdale Health Care - Osborn Campus
Scottsdale, Arizona, United States, 85258
Scottsdale Health Care - Shea Campus
Scottsdale, Arizona, United States, 85258
United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
El Camino Hospital
Mountain View, California, United States, 94040
Sacramento Heart and Vascular Research Center
Sacramento, California, United States, 95825
UC Davis Medical Center
Sacramento, California, United States, 95817
Alvarado Hospital
San Diego, California, United States, 92120
UCSD Medical Center
San Diego, California, United States, 92103
San Francisco General Hospital
San Francisco, California, United States, 94110
UCSF Moffitt-Long Hospital
San Francisco, California, United States, 94143
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Torrance Memorial Medical Center
Torrance, California, United States, 90503
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, Delaware
Christiana Care Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, United States, 33756
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
Cardiology Research Associates
Ormond Beach, Florida, United States, 32174
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
United States, Georgia
St. Joseph's Research Institute
Atlanta, Georgia, United States, 30342
Redmond Regional Medical Center
Rome, Georgia, United States, 30165
United States, Illinois
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Trinity Medical Center
Moline, Illinois, United States, 61265
Prairie Education & Research Cooperative
Springfield, Illinois, United States, 62701
United States, Indiana
St. Vincent Heart Center of Indiana/The Care Group LLC
Indianapolis, Indiana, United States, 46290
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70232
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
The Lahey Clinic
Burlington, Massachusetts, United States, 01803
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
St. Joseph's Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
United States, Missouri
St. Luke's / Mid America Heart Institute
Kansas City, Missouri, United States, 64111
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
NY Presbyterian / Weill Cornell Medical Center
New York, New York, United States, 10021
Lenox Hill Hospital
New York, New York, United States, 10021
Hudson Valley Heart Center
Poughkeepsie, New York, United States, 12601
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Carolina Cardiology Associates
High Point, North Carolina, United States, 27262
Wake Heart Research
Raleigh, North Carolina, United States, 27610
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
North Ohio Research, Ltd.
Elyria, Ohio, United States, 44035
Cleveland Cardiovascular Research Foundation
Fairview Park, Ohio, United States, 44126
United States, Oklahoma
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, United States, 73120
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Geisinger Clinic - Cardiology
Danville, Pennsylvania, United States, 17822
St. Vincent Health Center
Erie, Pennsylvania, United States, 16502
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
AnMed Health
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Black Hills Clinical Research Center
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Centennial Medical Center
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
South Austin Hospital
Austin, Texas, United States, 78704
Austin Heart P.A.
Austin, Texas, United States, 78756
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75226
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States, 76104
The Methodist Hospital
Houston, Texas, United States, 77030
University Hospital San Antonio (UTHSCSA)
San Antonio, Texas, United States, 78229
Tomball Regional Hospital
Tomball, Texas, United States, 77375
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Canada, Ontario
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, Canada, M5B 1W8
Canada, Quebec
Royal Victoria Hospital
Montréal, Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
Montréal, Quebec, Canada
Montréal Heart Institute
Montréal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel-Dieu
Montréal, Quebec, Canada
Hôpital Laval
Québec, Quebec, Canada
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:
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

ClinicalTrials.gov processed this record on April 22, 2014