Clinical Trial: Rivaroxaban for Patients With Antiphospholipid Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Rivaroxaban Versus Acenocumarol for Secondary Thromboprophylaxis in Patients With Antiphospholipid Syndrome: a Randomized, Prospective, Phase III Study. Analysis of Strati

Brief Summary: Long-term anticoagulation is widely used for secondary thromboprophylaxis in the antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment. Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism and non valvular atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis in patients with APS compared with acenocumarol

Detailed Summary: This is a phase 3 randomized, multicenter, non-inferiority open-label RCT. 190 eligible APS patients with arterial or venous thrombotic history receiving acenocumarol will be stratified according the presence of SLE and venous/arterial thrombotic history and randomized (1:1) either to continue vitamin K antagonists (standard of care, normalized ratio (INR) 2-3 or 2.5 to 3.5 in those with recurrent thrombotic episodes) or to switch to rivaroxaban (20 mg/day). The primary efficacy outcome is the development of any thrombotic event during the study period. Secondary efficacy outcomes include time to thrombosis, type of thrombosis (arterial or venous), overall causes of death, evaluation of a prognostic biomarker panel of recurrent thrombosis. The primary safety outcome will be major bleeding. Secondary safety outcomes include any adverse event and minor bleeding.
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome:

  • Developement of a new thrombotic event (arterial or venous), confirmed by appropiate imaging studies [ Time Frame: 36 months ]
  • Incidence of major bleeding [ Time Frame: 36 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of treatment-Emergent Adverse events [ Time Frame: 36 months ]
    i) all adverse events; ii) serious adverse events (SAE); iii) all bleeding events; iv) overall causes of death
  • Death due to thrombotic events [ Time Frame: 36 months ]
  • Time to the first thrombotic event [ Time Frame: 36 months ]
  • Type of thrombotic events (arterial or venous) [ Time Frame: 36 months ]
  • Evaluation of a prognostic biomarker panel [ Time Frame: 36 months ]
    Measuremnt of D-dimer, P-selectine and Von-willebrand factor


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: October 3, 2016
Date Started: March 2013
Date Completion: February 2018
Last Updated: October 5, 2016
Last Verified: October 2016