Comparison of rivaroxaban (Xarelto®; Bayer HealthCare), fixed-dose oral anticoagulant (blood thinner), versus warfarin in patients with antiphospholipid syndrome (called APS), with or without 'lupus' (systemic lupus erythematosus)

Phase 1

• Conditions: Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE).; MedDRA version: 14.1 Level: PT Classification code 10002817 Term: Antiphospholipid syndrome System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-002345-38-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-08
• Study Completion: 2015-06-08
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 116

Inclusion Criteria

1) Patients with thrombotic APS, with or without SLE, who have had either a single episode of VTE whilst not on anticoagulation or recurrent episode(s) which occurred whilst off anticoagulation or on sub-therapeutic anticoagulant therapy 2) Patients with a target INR of 2.5 (range 2.0 – 3.0) 3) Treated with warfarin for a minimum period of six months since last VTE 4) Female patients must be using adequate contraception with exception to postmenopausal or sterilised women
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1) Previous arterial thrombotic events due to APS 2) Recurrent venous thromboembolic events whilst on warfarin 3) Pregnant or lactating women 4) Severe renal impairment (creatinine clearance (calculated using the Cockcroft & Gault Equation Appendix A) < 30 mL/min (i.e. 29 mL/min or less)) 5) Liver function tests (ALT > 2 x ULN) 6) Thrombocytopenia (platelets < 75 x 10^9/L) 7) Non-compliance on warfarin (based on clinical assessment) 8) Patients on azole antifungals (e.g. ketoconazole, itraconazole, voriconazole and posaconazole) 9) Patents on Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. ritonavir) 10) Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine or phenobarbital) 11) Patients less than 18 years of age

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified