Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Completed · Phase 2
Conditions studied: Antiphospholipid Syndrome
In brief
The purpose of this study is to determine whether a drug named Fluvastatin is beneficial and safe in reducing the risk of cardiovascular disease and blood clots in patients with antiphospholipid antibodies or Antiphospholipid Syndrome (APS).
Key facts
- Study ID
- NCT00674297
- Run by
- Hospital for Special Surgery, New York
- People needed
- 41
- Starts
- 2008-05-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2018-05-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Persistently antiphospholipid-antibody positive patients (positive lupus anticoagulant test, anticardiolipin antibody ≥ 40 GPL /MPL, and/or anti- β2-glycoprotein I antibody > 20 SGU/SMU) with or without systemic lupus erythematosus
You may not qualify if…
- Younger than 18 year-old
- Pregnant
- Planning to get pregnant within the next 6 months
- Taking other cholesterol lowering agents
- Taking other immunosuppressive medications (such as methotrexate, azathioprine, cellcept, enbrel, remicade, or rituximab)(Hydroxychloroquine [Plaquenil] during the study period is allowed).
- Treatment with biologic agents including anti-TNF medications and Rituximab
- Treatment with erythromycin, itraconazole, or clarithromycin
- Taking prednisone higher than 10 mg daily
- Taking non-steroidal anti-inflammatory drug (such as Motrin, Advil, etc) regularly
- Have a muscle or liver disease
- Have chronic renal disease requiring dialysis
- Have hepatitis C and/or HIV infection
- Have active infections requiring antibiotics
- Have the diagnosis of a systemic autoimmune disease (such as rheumatoid arthritis or systemic sclerosis) other than lupus
- Have diagnosis of another chronic condition requiring corticosteroid treatment more than 10mg daily
- History of an allergic reaction to cholesterol lowering agents
Where it is running
- Hospital for Special Surgery — New York, New York, United States
- Division of Rheumatology, University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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