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 ]

To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.


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:

  1. The thrombosis incidence rate
  2. The effect of Hydroxychloroquine on mortality rate
  3. 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