Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients - Full Text View

Sponsor:	Hospital for Special Surgery, New York
Collaborator:	University of Texas
Information provided by:	Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT00674297

Purpose

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).

Condition	Intervention	Phase
Antiphospholipid Syndrome	Drug: Fluvastatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients

Resource links provided by NLM:

Drug Information available for: Fluvastatin

U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:

Pro-inflammatory and prothrombotic markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of fluvastatin in antiphospholipid antibody-positive patients [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluvastatin	Drug: Fluvastatin Fluvastatin 40 mg daily for 3 months

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674297

Locations

United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Texas
Division of Rheumatology, University of Texas Medical Branch
Galveston, Texas, United States, 77555

Sponsors and Collaborators

Hospital for Special Surgery, New York

University of Texas

Investigators

Principal Investigator:	Doruk Erkan, MD	Hospital for Special Surgery, New York
Principal Investigator:	Silvia Pierangeli, PhD	University of Texas

More Information

No publications provided

Responsible Party:	Doruk Erkan, MD, Hospital for Special Surgery
ClinicalTrials.gov Identifier:	NCT00674297 History of Changes
Other Study ID Numbers:	IRB 28005
Study First Received:	May 5, 2008
Last Updated:	July 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:

Persistently Antiphospholipid Antibody Positive Patients

Additional relevant MeSH terms:

Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012