GLORIA-AF Registry Program (Phase I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01428765
First received: August 25, 2011
Last updated: January 21, 2014
Last verified: January 2014
Results First Received: January 21, 2014  
Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Condition: Atrial Fibrillation

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

Participant Flow:   Overall Study
    All Patients  
STARTED     1063  
COMPLETED     1063  
NOT COMPLETED     0  



  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
All Patients No text entered.

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  1063  
Age  
[units: years]
Mean ± Standard Deviation
  68.2  ± 11.8  
Gender  
[units: participants]
 
Female     486  
Male     577  



  Outcome Measures
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1.  Primary:   CHADS2 Score   [ Time Frame: Baseline ]

2.  Primary:   CHA2DS2-VASc Score   [ Time Frame: Baseline ]

3.  Primary:   HAS-BLED Risk Score   [ Time Frame: Baseline ]

4.  Primary:   Antithrombotic Treatment Choice at Baseline   [ Time Frame: Baseline ]

5.  Primary:   Gender   [ Time Frame: Baseline ]

6.  Primary:   Age Group   [ Time Frame: Baseline ]

7.  Primary:   Medical History   [ Time Frame: Baseline ]

8.  Primary:   Concomitant Medication   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01428765     History of Changes
Other Study ID Numbers: 1160.114
Study First Received: August 25, 2011
Results First Received: January 21, 2014
Last Updated: January 21, 2014
Health Authority: China: Food and Drug Administration
Croatia: Agency for Medicinal Product and Medical Devices
Egypt:
Germany: Ethics Commission
Lebanon:
Netherlands:
Spain:
Turkey: Ministry of Health
United Arab. Emirates: