Antiphospholipid Syndrome Clinical Trial
Official title:
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).
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.
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