Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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17 August 2015 |
Main ID: |
EUCTR2012-001484-79-BE |
Date of registration:
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19/12/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety of Rivaroxaban in patients with nonvalvular atrial fibrillation who undergo catheter ablation
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Scientific title:
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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:
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10/01/2014 |
Target sample size:
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250 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001484-79 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Belgium
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France
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Germany
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United Kingdom
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United States
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Contacts
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Name:
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Larry Fields
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Address:
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1000 Route 202
08869
Raritan
United States |
Telephone:
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0119089274124 |
Email:
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lfields@its.jnj.com |
Affiliation:
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Janssen Scientific Affairs |
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Name:
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Larry Fields
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Address:
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1000 Route 202
08869
Raritan
United States |
Telephone:
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0119089274124 |
Email:
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lfields@its.jnj.com |
Affiliation:
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Janssen Scientific Affairs |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Have a documented history of paroxysmal (lasting <1 week), persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (= 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. 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 any 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo catheter ablation MedDRA version: 17.1
Level: PT
Classification code 10003658
Term: Atrial fibrillation
System Organ Class: 10007541 - Cardiac disorders
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Intervention(s)
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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-
Trade Name: Marevan Product Name: A vitamin K antagonist (VKA) used according to standard of care Pharmaceutical Form: Tablet
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Primary Outcome(s)
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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.
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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
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Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)
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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.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: From catheter ablation procedure to End of Treatment (30 ± 5 days)
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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.
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Secondary ID(s)
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2012-001484-79-DE
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RIVAROXAFL3002
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Source(s) of Monetary Support
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Bayer HealthCare AG
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Janssen Scientific Affairs
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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