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

June 15, 2011 updated by: Accumetrics, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: clopidogrel
oral, 450 mg loading dose on day of randomization; 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: clopidogrel
oral, 450 mg loading dose on day of randomization; 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Accumetrics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew J Price, M.D., Scripps Advanced Clnical Trials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P95082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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