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

Phase 2

Completed

• Conditions: Antiphospholipid Syndrome
• Interventions: Drug: Fluvastatin

• Registration Number: NCT00674297
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

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

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2011-07
• Study Completion: 2013-02
• Results First Submitted: 2017-04-21
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-29
• Last Update Submitted: 2018-03-29
• Results First Posted: 2018-05-01
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients	3 months	Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL)

Trial Locations

Locations (2)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Division of Rheumatology, University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States