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

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ClinicalTrials.gov Identifier: NCT00674297
Recruitment Status : Unknown
Verified February 2013 by Doruk Erkan, Hospital for Special Surgery, New York.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2008
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome Drug: Fluvastatin Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
Study Start Date : May 2008
Primary Completion Date : July 2011

Arms and Interventions

Arm Intervention/treatment
Experimental: Fluvastatin Drug: Fluvastatin
Fluvastatin 40 mg daily for 3 months

Outcome Measures

Primary Outcome Measures :
  1. Pro-inflammatory and prothrombotic markers [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety of fluvastatin in antiphospholipid antibody-positive patients [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674297

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

Responsible Party: Doruk Erkan, Principal Investigator, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00674297     History of Changes
Other Study ID Numbers: IRB 28005
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Doruk Erkan, Hospital for Special Surgery, New York:
Persistently Antiphospholipid Antibody Positive Patients

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors