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A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy (VENTURE-AF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01729871
First received: October 23, 2012
Last updated: December 3, 2015
Last verified: November 2015
Results First Received: October 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: rivaroxaban
Drug: uninterrupted vitamin K antagonist (VKA)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized at 37 sites in 5 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
248 participants were randomized correctly to study, with an equal number of participants randomized to both treatment arms. The intention to treat (ITT) analysis set includes all participants who were correctly randomized into study. There are 5 screen failures who were not included in ITT analysis set because they were incorrectly randomized.

Reporting Groups
  Description
Rivaroxaban Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
Vitamin K Antagonist Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.

Participant Flow:   Overall Study
    Rivaroxaban   Vitamin K Antagonist
STARTED   124   124 
COMPLETED   112   101 
NOT COMPLETED   12   23 
Adverse Event                7                7 
Death                0                1 
Lack of Efficacy                0                1 
Physician Decision                0                2 
Protocol Violation                1                0 
Withdrawal by Subject                0                3 
Unspecified                4                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rivaroxaban Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
Vitamin K Antagonist Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
Total Total of all reporting groups

Baseline Measures
   Rivaroxaban   Vitamin K Antagonist   Total 
Overall Participants Analyzed 
[Units: Participants]
 124   124   248 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.6  (9.86)   60.5  (10.51)   59.5  (10.21) 
Gender 
[Units: Participants]
     
Female   38   34   72 
Male   86   90   176 
Region of Enrollment 
[Units: Participants]
     
Belgium   24   24   48 
France   19   19   38 
Germany   18   19   37 
Great Britain   24   24   48 
United States of America   39   38   77 
Race 
[Units: Participants]
     
ASIAN   5   2   7 
BLACK   3   3   6 
N/A   4   3   7 
WHITE   112   116   228 
Ethnicity 
[Units: Participants]
     
HISPANIC/LATINO   0   4   4 
N/A   34   26   60 
NOT HISPANIC/LATINO   90   94   184 
Body-Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.8  (5.74)   28.9  (5.49)   29.4  (5.62) 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 81  (9.85)   79.4  (10.78)   80.2  (10.34) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 133.3  (15.6)   131.2  (17.68)   132.2  (16.67) 


  Outcome Measures
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1.  Primary:   Number of Participants With Incidence of Post-Procedure Major Bleeding Events   [ Time Frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure ]

2.  Secondary:   Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death   [ Time Frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure ]

3.  Secondary:   Number of Participants With Myocardial Infarction (MI)   [ Time Frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure ]

4.  Secondary:   Number of Participants With Ischemic Stroke   [ Time Frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure ]

5.  Secondary:   Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism   [ Time Frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure ]

6.  Secondary:   Number of Participants With Vascular Death   [ Time Frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Director Clinical Development
Organization: Janssen Scientific Affairs, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01729871     History of Changes
Other Study ID Numbers: CR100732
RIVAROXAFL3002 ( Other Identifier: Janssen Scientific Affairs, LLC )
2012-001484-79 ( EudraCT Number )
Study First Received: October 23, 2012
Results First Received: October 9, 2015
Last Updated: December 3, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices