Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
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|ClinicalTrials.gov Identifier: NCT00674297|
Recruitment Status : Unknown
Verified February 2013 by Doruk Erkan, Hospital for Special Surgery, New York.
Recruitment status was: Active, not recruiting
First Posted : May 7, 2008
Last Update Posted : February 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Syndrome||Drug: Fluvastatin||Phase 2|
The primary objective of the study is to determine the effects of fluvastatin on pro-thrombotic and pro-inflammatory markers in aPL-positive lupus and non-lupus patients (primary endpoint) and to determine the safety of fluvastatin in aPL-positive lupus and non-lupus patients (secondary endpoint).
All eligible patients will sign an IRB-approved consent form during the screening visit and give blood for baseline laboratory tests. Within a week of the screening visit, all patients will be started on Fluvastatin 40 mg daily for three months. At three months patients will be instructed to stop the study medication and they will be followed for another three months. Thus, the total duration of the study is six months: first three months is interventional and the last three months is observational.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients|
|Study Start Date :||May 2008|
|Primary Completion Date :||July 2011|
Fluvastatin 40 mg daily for 3 months
- Pro-inflammatory and prothrombotic markers [ Time Frame: 6 months ]
- Safety of fluvastatin in antiphospholipid antibody-positive patients [ Time Frame: 3 months ]
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): NCT00674297
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|United States, Texas|
|Division of Rheumatology, University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Doruk Erkan, MD||Hospital for Special Surgery, New York|
|Principal Investigator:||Silvia Pierangeli, PhD||University of Texas|