Antiphospholipid Syndrome Clinical Trial
Official title:
A Prospective, Randomized Clinical Trial Comparing Rivaroxaban vs Warfarin in High Risk Patients With Antiphospholipid Syndrome
Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of
Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR
2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute
thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleedings,
and death in triple aPL-positive APS patients.
Study Design A multicentre, interventional, prospective, parallel, randomised, controlled,
open-label, Rivaroxaban 20 mg qd (or 15mg qd in patients with moderate renal insufficiency)
vs warfarin (INR target 2.5), non-inferiority study, in 535 triple aPL-positive APS patients
in approximately 40 Internal Medicine and Thrombosis centres. Each local Institutional Review
Board will approve the study.
Study Population Patients of both sexes, of age 18-75, affected by anti-phospholipid
syndrome, with a high probability of recurrences as defined by triple aPL-positivity, are
eligible for this study.
Primary Outcome variables The primary cumulative outcome measure will be incident acute
thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or
death.
Secondary Outcome variables Separate evaluation of arterial and venous thrombosis and
all-cause death.
04.27.2015: An amendment has been made. Enrollment permitted till 75 years of age.
n/a
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