Rivaroxaban for Patients With Antiphospholipid Syndrome

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Treatments: Rivaroxaban

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