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

• Register: EUCTR
• Last refreshed on: 19 January 2015
• Main ID: EUCTR2012-001484-79-DE
• Date of registration: 16/10/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: Safety of Rivaroxaban in patients with nonvalvular atrial fibrillation who undergo catheter ablation
• Scientific title: A Randomized, Open-label, Active-controlled Multi-center Study to Evaluate the Safety of Rivaroxaban and Vitamin K Antagonists in Subjects Undergoing Catheter Ablation for Atrial Fibrillation - VENTURE-AF
• Date of first enrolment: 06/02/2013
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001484-79
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Vitamin K Antagonist (VKA) Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, France, Germany, United Kingdom, United States

Contacts

• Name: Larry Fields
• Affiliation: Janssen Scientific Affairs

• Name: Larry Fields
• Affiliation: Janssen Scientific Affairs

Key inclusion & exclusion criteria

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)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo catheter ablation
MedDRA version: 16.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders

Intervention(s)

Trade Name: Xarelto
Product Name: Rivaroxaban
Product Code: BAY 59-7939 (JNJ-39039039)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939 (JNJ-39039039)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: A vitamin K antagonist (VKA) used according to standard of care
Pharmaceutical Form: Tablet

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)

Secondary end point(s): The secondary endpoints for this study include:
• 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.
• 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.

Secondary ID(s)

RIVAROXAFL3002

Source(s) of Monetary Support

Bayer HealthCare AG

Janssen Scientific Affairs