This trial is active, not recruiting.

Condition antiphospholipid syndrome
Treatment fluvastatin
Phase phase 2
Sponsor Hospital for Special Surgery, New York
Collaborator University of Texas
Start date May 2008
End date July 2011
Trial size 60 participants
Trial identifier NCT00674297, IRB 28005


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Fluvastatin 40 mg daily for 3 months

Primary Outcomes

Pro-inflammatory and prothrombotic markers
time frame: 6 months

Secondary Outcomes

Safety of fluvastatin in antiphospholipid antibody-positive patients
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Principal investigator Doruk Erkan, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Hospital for Special Surgery, New York.