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

Hospital for Special Surgery, New York41 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Antiphospholipid Syndrome

Interventions

FluvastatinDRUG

Fluvastatin 40 mg daily for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital for Special Surgery

New York, New York, United States

Division of Rheumatology, University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

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)

Time frame: 3 months

Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients

Biomarker sTF (pM)

Time frame: 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)

Time frame: 3 months

Data from ClinicalTrials.gov

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