This trial is active, not recruiting.

Condition antiphospholipid syndrome
Treatments rivaroxaban, acenocumarol
Phase phase 3
Sponsor Hospital Universitari Vall d'Hebron Research Institute
Start date March 2013
End date October 2016
Trial size 190 participants
Trial identifier NCT02926170, 2010-019764-36


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Rivaroxaban 20 mg per day
rivaroxaban XARELTO
Rivaroxaban will be started at 20 mg/day. Dose will be adjusted according to Cr Clearance. Cr Clearance 30-49 ml/min will receive 15 mg/day.
(Active Comparator)
INR adjusted dose
acenocumarol SINTROM
Doses will be adjusted according to INR

Primary Outcomes

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

Secondary Outcomes

Incidence of treatment-Emergent Adverse events
time frame: 36 months
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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Patients with thrombotic antiphsopholipd syndrome - Treated with acenocumarol for a minimum period of 6 months - Positivity for Lupus anticoagulant and/or anti-cardiolipin or anti-B2GPI antibodies IgG or IgM≥40 Exclusion Criteria: - Major haemorrhage (cerebral or gastrointestinal) within the previous 6 months - Neurosurgery within the previous 4 weeks - Any surgery within the previous 10 days - Active peptic ulcus - ALT or GPT >120 UI/mL non-lupus related in the previous 30 days - Platelets <30x10E9 in the previous 30 days - Recent diagnosed malignancy - Any criteria listed in the summary of the produt characterisitcs (SPC) - Renal disease with a creatinine clearance <30 mL/min or with a known uncontrolled renal disease - Concomitant administration of drugs that could interfere with CYP3A4

Additional Information

Official title Rivaroxaban Versus Acenocumarol for Secondary Thromboprophylaxis in Patients With Antiphospholipid Syndrome: a Randomized, Prospective, Phase III Study. Analysis of Stratification Prognostic Factors
Principal investigator Josefina Cortes, MD,pHD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute.