Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT COM)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Medtronic
Information provided by (Responsible Party):
Alexandru B Chicos, Northwestern University
ClinicalTrials.gov Identifier:
NCT01706146
First received: October 10, 2012
Last updated: February 23, 2016
Last verified: February 2016
Results First Received: January 25, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Intervention: Drug: Non-coumadin Oral Anticoagulant

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Non-Coumadin Oral Anticoagulant

Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.

Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.


Participant Flow:   Overall Study
    Non-Coumadin Oral Anticoagulant  
STARTED     59  
COMPLETED     53 [1]
NOT COMPLETED     6  
Withdrawal by Subject                 1  
Adverse Event                 3  
Developed AF and need for antiplatelets                 2  
[1] 1 pt developed permanent AF; 1 pt needed dual antiplatelet therapy; 3 possible TIA; 1 withdraw



  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
Non-Coumadin Oral Anticoagulant

Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.

Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.


Baseline Measures
    Non-Coumadin Oral Anticoagulant  
Number of Participants  
[units: participants]
  59  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     38  
Age  
[units: year]
Mean (Standard Deviation)
  66.8  (7.7)  
Gender  
[units: participants]
 
Female     15  
Male     44  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     2  
White     55  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Canada     12  
United States     47  



  Outcome Measures
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1.  Primary:   Number of Days on Anticoagulation   [ Time Frame: up to 12 months ]

2.  Secondary:   Bleeding Incidence   [ Time Frame: up to 12 months ]

3.  Other Pre-specified:   Stroke Rate   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Other Pre-specified:   Overall Survival   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Other Pre-specified:   Major Bleeding-free Survival Rate   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Other Pre-specified:   Stroke-free Survival Rate   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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 NOT 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.


Results Point of Contact:  
Name/Title: Adin-Cristian Andrei, Ph.D.
Organization: Northwestern University
phone: 312-694-0509
e-mail: Adin-Cristian.Andrei@nm.org


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

Responsible Party: Alexandru B Chicos, Northwestern University
ClinicalTrials.gov Identifier: NCT01706146     History of Changes
Other Study ID Numbers: STU00064217
1R34HL113404-01 ( US NIH Grant/Contract Award Number )
7R34HL113404-03 ( US NIH Grant/Contract Award Number )
Study First Received: October 10, 2012
Results First Received: January 25, 2016
Last Updated: February 23, 2016
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board