Rivaroxaban in Antiphospholipid Syndrome (RAPS)

Phase 2

Completed

• Conditions: Thrombotic antiphospholipid syndrome, with or without systemic lupus erythematosus; Musculoskeletal Diseases

• Registration Number: ISRCTN68222801
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Current inclusion criteria as of 02/10/2013:
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 three months since last VTE
4. Female patients must be using adequate contraception with the exception of postmenopausal or sterilised women

Previous 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

Exclusion Criteria

Current exclusion criteria as of 02/10/2013:
1. Previous arterial thrombotic events due to APS
2. Recurrent venous thromboembolic events whilst on warfarin at a therapeutic INR of 2.0-3.0
3. Pregnant or lactating women
4. Severe renal impairment (creatinine clearance [calculated using the Cockcroft & Gault formula Appendix A] < 30 mL/min (i.e. 29 mL/min or less)
5. Liver function tests ALT > 2 x ULN
6. Cirrhotic patients with Child Pugh B or C
7. Thrombocytopenia (platelets < 75 x 10^9/L)
8. Non-compliance on warfarin (based on clinical assessment)
9. Patients on azole antifungals (e.g. ketoconazole, itraconazole, voriconazole and posaconazole)
10. Patients on Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. ritonavir)
11. Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St John's Wort)
12. Patients less than 18 years of age
13. Refusal to consent to the site informing GP and healthcare professional responsible for anticoagulation care, of participation

Previous exclusion criteria:
1. Previous arterial thrombotic events due to APS
2. Recurrent venous thromboembolic events whilst on warfarin at a therapeutic INR of 2.0-3.0
3. Pregnant or lactating women
4. Severe renal impairment (creatinine clearance [calculated using the Cockcroft & Gault formula Appendix A of the protocol] < 30 mL/min (i.e. 29 mL/min or less)
5. Liver function tests ALT > 2 x ULN
6. Cirrhotic patients with Child Pugh B or C
7. Thrombocytopenia (platelets < 75 x 10^9/L)
8. Non-compliance on warfarin (based on clinical assessment)
9. Patients on azole antifungals (e.g. ketoconazole, itraconazole, voriconazole and posaconazole)
10. Patents on Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. ritonavir)
11. Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine or phenobarbital)
12. Patients less than 18 years of age
13. Refusal to consent to CTU informing GP of participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage change in ETP from randomisation to day 42

Secondary Outcome Measures

Name	Time	Method
1. Efficacy<br>2. Safety<br>3. Quality of life (QoL)<br>4. Laboratory assessment of compliance