Official Title: “Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients”

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).

Study Type: Interventional

Study Design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin
  • Fluvastatin 40 mg daily for 3 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Fluvastatin

Primary Measures

• Pro-inflammatory and prothrombotic markers
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Safety of fluvastatin in antiphospholipid antibody-positive patients
  • Time Frame: 3 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital for Special Surgery, New York

Overall Clinical Trial Officials and Contacts

Doruk Erkan, MD Principal Investigator Hospital for Special Surgery  

Overall Contact: Joann Vega 212 774 2795 vegaj@hss.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674297

Study ID Number: IRB 28005

ClinicalTrials.gov Identifier: NCT00674297

Health Authority: United States: Institutional Review Board