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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Doruk Erkan, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00674297
First received: May 5, 2008
Last updated: February 3, 2013
Last verified: February 2013
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Principal Investigator, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00674297     History of Changes
Other Study ID Numbers: IRB 28005
Study First Received: May 5, 2008
Last Updated: February 3, 2013
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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014