Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
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|ClinicalTrials.gov Identifier: NCT01784523|
Recruitment Status : Terminated (low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.)
First Posted : February 6, 2013
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Syndrome||Drug: Hydroxychloroquine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 30, 2015|
|Actual Study Completion Date :||September 30, 2015|
No Intervention: Standard treatment
patients randomized to standard treatment will not receive hydroxychloroquine.
Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.
Other Name: plaquenil
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784523
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Doruk Erkan, MD||Hospital for Special Surgery, New York|