Clinical Trial: Clopidogrel and Aspirin for the Treatment of Polycythemia Vera

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: MPD-RC 108: Phase II, Randomized, Double-Blind, Placebo Controlled International Study of Clopidogrel and Aspirin for the Treatment of Polycythemia Vera

Brief Summary:

Clopidogrel (Plavix) and aspirin are two antithrombotic agents (blood thinners) commonly used in patients with previous thrombotic events (stroke or heart attack). Thrombosis is the formation of a blood clot in a blood vessel. Patients with polycythemia vera are routinely treated with aspirin which has been shown to be effective in reducing their thrombotic risk. However, in polycythemia vera patients with previous thrombosis, a further benefit might be obtained by using the combination of aspirin and clopidogrel which is routinely used in patients with recent acute myocardial ischemia (reduced blood supply to the heart muscle). The study will assess whether this combination therapy greatly increases the risk of bleeding versus aspirin alone, if clopidogrel reduces biological factors that might lead to a stroke or heart attack, and whether a high number of patients with polycythemia vera are resistant to clopidogrel.

Approximately 200 subjects will be enrolled to the Myeloproliferative Disorders-Research Consortium (MPD-RC) study in Europe and the United States with participation expected to last for 7 months (6 months of receiving study medication plus a 30 day follow-up visit).

Detailed Summary:
Sponsor: Ronald Hoffman

Current Primary Outcome: To determine the safety and efficacy of using Clopidogrel plus aspirin on Polycythemia Vera patients [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: July 14, 2009
Date Started: June 2009
Date Completion:
Last Updated: November 24, 2014
Last Verified: November 2014