NCT02157272

Rivaroxaban in Thrombotic Antiphospholipid Syndrome

A Prospective, Randomized Clinical Trial Comparing Rivaroxaban vs Warfarin in High Risk Patients With Antiphospholipid Syndrome

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Antiphospholipid Syndrome

Interventions

Type	Name	Description
DRUG	Experimental: Rivaroxaban	The investigated drug is Rivaroxaban 20mg, a film coated tablet, which is a highly selective direct factor Xa inhibitor. It should be administered orally, every day at any time (always the same), with food. The treatment should be performed for all the treatment period.

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-01-25
• Completion: 2018-01-25
• First posted: 2014-06-05
• Last updated: 2018-01-30

Locations

1 site across 1 country: Italy