Rivaroxaban for Patients With Antiphospholipid Syndrome

NCT ID: NCT02926170

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-13
• Study Completion Date: 2017-12-31

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 acenocoumarol

Detailed 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.

Conditions

Antiphospholipid Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rivaroxaban

Rivaroxaban 20 mg per day

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

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.

acenocumarol

INR adjusted dose

Group Type: ACTIVE_COMPARATOR

acenocumarol

Intervention Type: DRUG

Doses will be adjusted according to INR

Interventions

Rivaroxaban

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.

Intervention Type: DRUG

acenocumarol

Doses will be adjusted according to INR

Intervention Type: DRUG

Other Intervention Names

XARELTO; SINTROM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josefina Cortes, MD,pHD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron Research Institute

Locations

Vall d'Hebron University Hospital

Barcelona, , Spain

Countries

Spain

Other Identifiers

2010-019764-36

Identifier Type: -

Identifier Source: org_study_id