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Coronary ArteriosclerosisGRAVITASNCT00645918

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

A study testing clopidogrel in people with Coronary Arteriosclerosis and Acute Coronary Syndrome, run by Accumetrics, Inc. at 82 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,800 participants
Where
82 sitesin 2 countries
Study dates
Jun 2008to Oct 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.
  • 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

Trial locations and contacts

82 sites in 2 countries.

82 sites in 2 countries

United States72 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • St. Joseph's Research Institute

    Atlanta, Georgia, 30342

  • South Austin Hospital

    Austin, Texas, 78704

  • Austin Heart P.A.

    Austin, Texas, 78756

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • The Lahey Clinic

    Burlington, Massachusetts, 01803

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Jesse Brown VA Medical Center

    Chicago, Illinois, 60612

  • University of Illinois Medical Center

    Chicago, Illinois, 60612

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Clinic - Cardiology

    Danville, Pennsylvania, 17822

  • St. Mary's Duluth Clinic Health System

    Duluth, Minnesota, 55805

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • North Ohio Research, Ltd.

    Elyria, Ohio, 44035

  • St. Vincent Health Center

    Erie, Pennsylvania, 16502

  • Cleveland Cardiovascular Research Foundation

    Fairview Park, Ohio, 44126

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Carolina Cardiology Associates

    High Point, North Carolina, 27262

  • The Methodist Hospital

    Houston, Texas, 77030

  • St. Vincent Heart Center of Indiana/The Care Group LLC

    Indianapolis, Indiana, 46290

  • University of Florida Health Science Center

    Jacksonville, Florida, 32209

  • St. Luke's / Mid America Heart Institute

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Trinity Medical Center

    Moline, Illinois, 61265

  • El Camino Hospital

    Mountain View, California, 94040

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70232

  • Lenox Hill Hospital

    New York, New York, 10021

  • NY Presbyterian / Weill Cornell Medical Center

    New York, New York, 10021

  • Christiana Care Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Oklahoma Cardiovascular Associates

    Oklahoma City, Oklahoma, 73120

  • Cardiology Research Associates

    Ormond Beach, Florida, 32174

  • Cardiac and Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Wake Heart Research

    Raleigh, North Carolina, 27610

  • Black Hills Clinical Research Center

    Rapid City, South Dakota, 57701

  • Redmond Regional Medical Center

    Rome, Georgia, 30165

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Sacramento Heart and Vascular Research Center

    Sacramento, California, 95825

  • University Hospital San Antonio (UTHSCSA)

    San Antonio, Texas, 78229

  • UCSD Medical Center

    San Diego, California, 92103

  • Alvarado Hospital

    San Diego, California, 92120

  • San Francisco General Hospital

    San Francisco, California, 94110

  • UCSF Moffitt-Long Hospital

    San Francisco, California, 94143

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Scottsdale Health Care - Osborn Campus

    Scottsdale, Arizona, 85258

  • Scottsdale Health Care - Shea Campus

    Scottsdale, Arizona, 85258

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62701

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Tomball Regional Hospital

    Tomball, Texas, 77375

  • Torrance Memorial Medical Center

    Torrance, California, 90503

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

  • St. Joseph's Mercy Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada10 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • McMaster University

    Hamilton, Ontario

  • Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel-Dieu

    Montreal, Quebec

  • Hôpital du Sacré-Coeur de Montréal

    Montreal, Quebec

  • Montréal Heart Institute

    Montreal, Quebec

  • Royal Victoria Hospital

    Montreal, Quebec

  • York PCI Group

    Newmarket, Ontario

  • University of Ottawa Heart Institute

    Ottawa, Ontario

  • Hôpital Laval

    Québec, Quebec

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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.

Being tested
clopidogrel, placebo
Keywords
Platelets, Platelet Function Tests, Clopidogrel, Drug Eluting Stents, Acute Coronary Syndrome, Myocardial Ischemia, Stent Thrombosis, Heart Diseases, Coronary Disease, Arterial Occlusive Disease
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases, Coronary Disease, Arterial Occlusive Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clopidogrelDrug

    oral, 75 mg daily for 6 months starting on day of randomization

  • placeboDrug

    oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization

  • clopidogrelDrug

    oral, 450 mg loading dose on day of randomization; 75 mg daily for 6 months starting on day of randomization

Study groups in NCT00645918
Study groupRoleWhat they receive
AActive comparator"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.
Receives: Drug: clopidogrel
BPlacebo comparator"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.
Receives: Drug: clopidogrel; Drug: placebo
CPlacebo comparatorResponders: 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.
Receives: Drug: clopidogrel; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

Secondary outcomes (1)

  1. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00645918
Sponsor's protocol ID
P95082
Acronym
GRAVITAS
Status last verified
Jun 2011
First submitted
24 Mar 2008
Last updated
16 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Price MJ, Angiolillo DJ, Teirstein PS, Lillie E, Manoukian SV, Berger PB, Tanguay JF, Cannon CP, Topol EJ. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation. 2011 Sep 6;124(10):1132-7. doi: 10.1161/CIRCULATIONAHA.111.029165. Epub 2011 Aug 29.

    PubMed 21875913

  • Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290.

    PubMed 21406646

  • Price MJ, Berger PB, Angiolillo DJ, Teirstein PS, Tanguay JF, Kandzari DE, Cannon CP, Topol EJ. Evaluation of individualized clopidogrel therapy after drug-eluting stent implantation in patients with high residual platelet reactivity: design and rationale of the GRAVITAS trial. Am Heart J. 2009 May;157(5):818-24, 824.e1. doi: 10.1016/j.ahj.2009.02.012.

    PubMed 19376306

Questions about this trial

What is this clinical trial studying?

A study testing clopidogrel in people with Coronary Arteriosclerosis and Acute Coronary Syndrome, run by Accumetrics, Inc. at 82 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00645918, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.

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