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

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ClinicalTrials.gov Identifier: NCT01729871

Recruitment Status : Completed

First Posted : November 20, 2012

Results First Posted : November 10, 2015

Last Update Posted : March 6, 2017

Sponsor:

Collaborator:

Bayer

Information provided by (Responsible Party):

Janssen Scientific Affairs, LLC

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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
Other	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.
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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)

Sex: Female, Male [Units: Participants] Count of Participants
Female	38 30.6%	34 27.4%	72 29.0%
Male	86 69.4%	90 72.6%	176 71.0%

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 ]

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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 ]

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3. Secondary:

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

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4. Secondary:

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

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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 ]

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6. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

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):

Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G, Vijgen J, Hügl BJ, Balasubramaniam R, De Chillou C, Davies DW, Fields LE, Natale A; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.

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 )
First Submitted:	October 23, 2012
First Posted:	November 20, 2012
Results First Submitted:	October 9, 2015
Results First Posted:	November 10, 2015
Last Update Posted:	March 6, 2017

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