Coronary Artery Disease - GRAVITAS

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Trial Sponsor
Accumetrics

Principal Investigator
Gregory Mishkel, MD

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

Purpose
Previous studies have shown that patients respond different to antiplatelet medication (makes your blood less sticky) such as clopidogrel (plavix). These patients have a high degree of platelet reactivity and are at greater risk of a major adverse cardiac event (MACE), such as cardiovascular death, heart attack or stent blockage. The trial objective is to determine if patient outcomes are improved when dosing is tailored to the patient's response to clopidogrel as determined using the VerifyNow P2Y12 test after drug-eluting stent implantation.

Ages Eligible for Study
18 years or older

Genders Eligible for Study
Both

Inclusion Criteria

• Patient undergoing tretment to Coronary Artery with planned placement of drug-eluting stent (DES).
• 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

Exclusion Criteria

• Any cardiac intervention within previous 30-days (stent or balloon)
• History of gastro-intestinal bleeding within 6 months.
• Non-cardiac surgery within 6 weeks.
• Stroke within 6 weeks.
• 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
• Patients unwilling or unable to complete clinical follow-up for the duration of the study

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