Clopidogrel and Aspirin for the Treatment of Polycythemia Vera
Status:
Withdrawn
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Ronald Hoffman
Collaborators:
Myeloproliferative Disorders-Research Consortium National Cancer Institute (NCI)