Clinical Trial: Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
Brief Summary: In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.
Detailed Summary: Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.
Sponsor: Hospital for Special Surgery, New York
Current Primary Outcome: Incident acute thrombosis [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: thrombosis incidence rate [ Time Frame: 5 years ]
In persistently aPL-positive patients with no other systemic autoimmune diseases, to determine:
- The thrombosis incidence rate
- The effect of Hydroxychloroquine on mortality rate
- The effect of Hydroxychloroquine on aPL profile
Original Secondary Outcome: Same as current
Information By: Hospital for Special Surgery, New York
Dates:
Date Received: February 3, 2013
Date Started: February 2013
Date Completion: February 2020
Last Updated: March 20, 2017
Last Verified: March 2017