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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome: Pro-inflammatory and prothrombotic markers [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Hospital for Special Surgery, New York

Dates:
Date Received: May 5, 2008
Date Started: May 2008
Date Completion:
Last Updated: February 3, 2013
Last Verified: February 2013