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

Study Overview
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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).

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.

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

Conditions
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Antiphospholipid Syndrome

Intervention / Treatment
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* Drug: Fluvastatin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluvastatin<br>All patients will take Fluvastatin 40 mg daily for 3 months. | Drug: Fluvastatin<br>* Fluvastatin 40 mg daily for 3 months<br>* Other names: Lescol, Lescol XL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | Biomarkers: IL6 (pg/mL), IL1β (pg/mL), IL8 (pg/mL), VEGF (pg/mL), TNFα (pg/mL), IFNα (pg/mL), IP10 (pg/mL), sCD40L (pg/mL) | 3 months | 
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | Biomarker sTF (pM) | 3 months | 
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistently Antiphospholipid Antibody Positive Patients