Rivaroxaban for Patients With Antiphospholipid Syndrome

Vall d'Hebron University Hospital (HUVH)

Status and phase

Completed

Phase 3

Conditions

Antiphospholipid Syndrome

Treatments

Drug: Rivaroxaban

Drug: acenocumarol

Study type

Interventional

Funder types

Other

Identifiers

NCT02926170

2010-019764-36

Details and patient eligibility

About

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 acenocoumarol

Full description

This is a phase 3 randomized, multicenter, non-inferiority open-label RCT. 190 eligible APS patients with arterial or venous thrombotic history receiving acenocoumarol 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.

Enrollment

190 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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