Safety of Rivaroxaban in patients with nonvalvular atrial fibrillation who undergo catheter ablatio

• Conditions: Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo catheter ablation; MedDRA version: 16.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001484-79-DE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-16
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Have a documented history of paroxysmal (lasting <1 week), or persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent in (= 1 year) NVAF.
• Be scheduled for a catheter ablation procedure for NVAF.
• Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
• Be suitable for anticoagulant therapy (ie, CHADS2 or CHA2DS2-VASc score =1)
and catheter ablation as per the judgment of the investigator. (4.1- Criterion modified per amendment)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 147
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 103

Exclusion Criteria

• Has contraindications to the use of anticoagulant therapy (eg, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy or a platelet count <90,000/µL documented at screening).
• Has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure.
• Has a history of a prior stroke, TIA or non-convulsive status epilepticus within 6 months of the screening visit.
• Has a CrCl = 50 mL/min at screening
• Has moderate to severe hepatic impairment (Child-Pugh B and C).
• Has a comorbid condition such as severe pulmonary disease, infection, etc., and a life expectancy of less than 6 months.
• Has contraindications to the use of anticoagulant therapy (eg, bleeding diathesis,
history of gastrointestinal bleeding within 1 year or coagulopathy or a platelet count
<90,000/uL documented at screening, or uncontrolled hypertension). (10.1 -Criterion modified per amendment)
• Has moderate to severe hepatic impairment (Child-Pugh B and C; ie, alanine
aminotransferase [ALT] >5 x upper limit of normal [ULN] or ALT >3 x ULN plus total
bilirubin >2 x ULN using laboratory values from the screening period). (12.1 -Criterion modified per amendment)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult subjects with nonvalvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.;Secondary Objective: The secondary objective is to evaluate the thromboembolism profile of rivaroxaban and uninterrupted VKA as measured by the composite and the individual components of the following post procedure events: myocardial infarction (MI), ischemic stroke, non-CNS systemic embolism, and vascular death.;Primary end point(s): The primary endpoint for this study is the incidence of post-procedure major bleeding events observed within the first 30 ± 5 days after the catheter ablation procedure;Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints for this study include:<br>•Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death. <br>•Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the individual components of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death.;Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)