Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
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).
|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|
- Pro-inflammatory and prothrombotic markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety of fluvastatin in antiphospholipid antibody-positive patients [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Fluvastatin 40 mg daily for 3 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Doruk Erkan, MD||Hospital for Special Surgery, New York|
|Principal Investigator:||Silvia Pierangeli, PhD||University of Texas|