Status:
COMPLETED
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
University of Texas
Conditions:
Antiphospholipid Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 antib...
Detailed 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 dete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00674297
Start Date
May 1 2008
End Date
February 1 2013
Last Update
May 1 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital for Special Surgery
New York, New York, United States, 10021
2
Division of Rheumatology, University of Texas Medical Branch
Galveston, Texas, United States, 77555