Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborator: University of Texas
• Treatments: Fluvastatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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