Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: November 2, 2012
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: June 30, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Atrial Fibrillation

  Participant Flow
  Hide 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  
COMPLETED     2120  

  Baseline Characteristics
  Hide 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  
Number of Participants  
[units: participants]
Age [1]
[units: years]
Mean ± Standard Deviation
  75.2  ± 8.8  
Gender [2]
[units: participants]
Female     1015  
Male     1101  
[1] For 5 patients the documentation of date of birth is missing, so age could be calculated for N=2115 patients.
[2] 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
  Hide 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
  Hide 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

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT01721837     History of Changes
Other Study ID Numbers: 1160.170
Study First Received: November 2, 2012
Results First Received: June 30, 2014
Last Updated: June 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices