NCT00940784

Clopidogrel and Aspirin for the Treatment of Polycythemia Vera

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ronald Hoffman · Academic / Other
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	Clopidogrel (Plavix)	Clopidogrel, aspirin plus hydroxyurea 75mg qd (Plavix) + 81 - 100 mg qd (aspirin) + hydroxyurea
DRUG	Placebo	Placebo, aspirin (81-100 mg qd) plus hydroxyurea
DRUG	Aspirin	81-100 mg qd

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-07-16
• Last updated: 2014-11-26