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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Antiphospholipid Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fluvastatin

All patients will take Fluvastatin 40 mg daily for 3 months.

Group Type EXPERIMENTAL

Fluvastatin

Intervention Type DRUG

Fluvastatin 40 mg daily for 3 months

Interventions

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Fluvastatin

Fluvastatin 40 mg daily for 3 months

Intervention Type DRUG

Other Intervention Names

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Lescol, Lescol XL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No