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

Hospital for Special Surgery (HSS)

Status and phase

Completed

Phase 2

Conditions

Antiphospholipid Syndrome

Treatments

Drug: Fluvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00674297

IRB 28005

Details and patient eligibility

About

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).

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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