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8110 Gatehouse Road, Falls Church, VA 22042

Influence of Vorapaxar on Thrombin Generation and Coagulability

General Information

Age Group

Adult

Status

Active

Start and Complete Date

21-Nov-2019

Protocol Number

NCT02629367

Background Information

PAR-1 receptor inhibition is an emerging therapeutic strategy in patients who have suffered ACS or have peripheral vascular disease (PAD). Vorapaxar is a novel antiplatelet agent that selectively inhibits the cellular actions of thrombin through antagonism of PAR-1. The primary objective is to determine the onset-, maintenance-, and offset-effects of vorapaxar on thrombin generation kinetics (clotting time, thrombin generation, platelet-fibrin clot strength, and clot lysis) and endothelial function in antiplatelet naïve patients and patients on mono-and dual-antiplatelet therapy.

Offered At

Inova Heart and Vascular Institute
Center for Thrombosis Research and Drug Development
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator and Sub-Investigator:
Paul A. Gurbel, MD
Hamid Taheri, MD

Eligibility Information

  • 18 to 75 years
  • Subject must have multiple risk factors of developing atherosclerosis, or evidence of a history of atherosclerosis involving the coronary or peripheral arterial systems as follows:
    • Subject must have at least 2 cardiovascular risk factors such as high blood pressure, high cholesterol, diabetes, obesity, current smokers, 55 years or older, or
    • History of myocardial infarction (heart attack )
    • History of peripheral artery disease

Ineligibility Information

  • Older than 75 years
  • Current use of anticoagulants (warfarin, oral factor Xa inhibitor, or oral direct thrombin inhibitor)
  • History of major bleeding, or evidence of active abnormal bleeding
  • History of TIA or stroke
  • Severe valve heart disease
  • Invasive surgery within 30 days or is anticipating one during the course of their study participation