Clopidogrel and Aspirin for the Treatment of Polycythemia Vera

Phase 2

Withdrawn

• Conditions: Polycythemia Vera
• Interventions: Drug: Placebo; Drug: Clopidogrel (Plavix); Drug: Aspirin

• Registration Number: NCT00940784
• Lead Sponsor: Ronald Hoffman

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 Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will be randomized placebo in addition to low dose aspirin and hydroxyurea
Clopidogrel	Clopidogrel (Plavix)	Subjects will be randomized to clopidogrel (oral-75 mg per day) in addition to low dose aspirin and hydroxyurea
Placebo	Aspirin	Subjects will be randomized placebo in addition to low dose aspirin and hydroxyurea
Clopidogrel	Aspirin	Subjects will be randomized to clopidogrel (oral-75 mg per day) in addition to low dose aspirin and hydroxyurea

Primary Outcome Measures

Name	Time	Method
To determine the safety and efficacy of using Clopidogrel plus aspirin on Polycythemia Vera patients	2 years