Clinical trial NCT00674297: Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Official title: Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antiphospholipid Syndrome
Keywords: Persistently Antiphospholipid Antibody Positive Patients
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2008-05-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
timeFrame: 3 months
measure: Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
timeFrame: 3 months
measure: Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Galveston
country: United States
facility: Division of Rheumatology, University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Doruk Erkan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Silvia Pierangeli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erkan D, Willis R, Murthy VL, Basra G, Vega J, Ruiz-Limon P, Carrera AL, Papalardo E, Martinez-Martinez LA, Gonzalez EB, Pierangeli SS. A prospective open-label pilot study of fluvastatin on proinflammatory and prothrombotic biomarkers in antiphospholipid antibody positive patients. Ann Rheum Dis. 2014 Jun;73(6):1176-80. doi: 10.1136/annrheumdis-2013-203622. Epub 2013 Aug 9.