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Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment

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ClinicalTrials.gov Identifier: NCT01721837
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Atrial Fibrillation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Reasons for exclusion from analysis: 25 patients were documented as having severe renal impairment (RI), 1643 patients were acc. to documentation either not renally impaired or degree of RI was unknown or missing. Acc. to documentation 120 patients had valvular atrial fibrillation (AF), in 922 patients the origin of AF was unknown or missing.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4340 patients were enrolled in the study, 2220 patients had no documented mild or moderate renal impairment or no documented non valvular atrial fibrillation. Therefore, 2120 patients remained for analysis.

Reporting Groups
All Patients All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).

Participant Flow:   Overall Study
    All Patients
STARTED   2120 

  Baseline Characteristics

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.
All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).

Reporting Groups
All Patients All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 75.2  (8.8) 
[1] For 5 patients the documentation of date of birth is missing, so age could be calculated for N=2115 patients.
Gender [1] 
[Units: Participants]
Female   1015 
Male   1101 
[1] For 4 patients the documentation of gender is missing.

  Outcome Measures

1.  Primary:   Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)   [ Time Frame: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate ]

  Serious Adverse Events

  Other Adverse Events

  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
This non-interventional studies is conducted according to §67, section 6 German Medicines Act. The term ‚principal investigator‘ is not applicable.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01721837     History of Changes
Other Study ID Numbers: 1160.170
First Submitted: November 2, 2012
First Posted: November 6, 2012
Results First Submitted: June 30, 2014
Results First Posted: July 31, 2014
Last Update Posted: July 31, 2014