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

Completed · Not applicable · Has a placebo group

Conditions studied: Coronary Arteriosclerosis, Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT00645918

Run by

Accumetrics, Inc.

People needed

2800

Starts

2008-06-01

Expected to finish

2010-10-01

Last updated by the study team

2011-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Scottsdale Health Care - Osborn Campus — Scottsdale, Arizona, United States
• Scottsdale Health Care - Shea Campus — Scottsdale, Arizona, United States
• Scripps Green Hospital — La Jolla, California, United States
• El Camino Hospital — Mountain View, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Sacramento Heart and Vascular Research Center — Sacramento, California, United States
• UCSD Medical Center — San Diego, California, United States
• Alvarado Hospital — San Diego, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• UCSF Moffitt-Long Hospital — San Francisco, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Christiana Care Hospital — Newark, Delaware, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida, United States
• University of Florida Health Science Center — Jacksonville, Florida, United States
• Cardiology Research Associates — Ormond Beach, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• St. Joseph's Research Institute — Atlanta, Georgia, United States
• Redmond Regional Medical Center — Rome, Georgia, United States
• Jesse Brown VA Medical Center — Chicago, Illinois, United States
• University of Illinois Medical Center — Chicago, Illinois, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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