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

Study Status

Closed to Enrollment

Study Description

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 (PV) 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).

This study will assess whether this combination therapy greatly increases the risk of bleeding compared to 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.  Study participation is expected to last for 7 months (6 months receiving study medication plus a 30 day follow-up visit).

Disease Status and/or Stage

Polycythemia Vera (PV)

Sponsor

Myeloproliferative Disorders-Research Consortium

Key Eligibility

  • Men and women age 18 to 81
  • Diagnosed with polycythemia vera (PV) within 5 years of study entry
  • High cardiovascular risk due to having experienced a prior vascular event such as:
    • Ischemic (clots) stroke
    • Myocardial infarcation (heart attack)
    • Venous thromboembolism (blood clot in vein)
  • Women of childbearing potential must agree to practice effective methods of birth control during the study and for 30 days thereafter
  • More detailed eligibility criteria will be discussed when you contact the study team

Principal Investigator

Richard Silver, MD

Contact

Healthy Volunteers

healthy_volunteers.jpg

As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.

Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

Top of page