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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
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Atrial Fibrillation
Enrollment 4340

Recruitment Details 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 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.
Arm/Group Title All Patients
Hide Arm/Group Description All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).
Period Title: Overall Study
Started 2120
Completed 2120
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
Overall Number of Baseline Participants 2120
Hide Baseline Analysis Population Description
All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2120 participants
75.2  (8.8)
[1]
Measure Description: For 5 patients the documentation of date of birth is missing, so age could be calculated for N=2115 patients.
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2120 participants
Female 1015
Male 1101
[1]
Measure Description: For 4 patients the documentation of gender is missing.
1.Primary Outcome
Title Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)
Hide Description The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.
Time Frame One single observation time point: at the time of prescription before the first intake of dabigatran etexilate
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with documented mild or moderate renal impairment and non-valvular atrial fibrillation (PPS) having evaluable data for age, gender, body weight, and serum creatinine. In 145 patients age, gender, serum creatinine or weight was missing so that Creatinine Clearance according to the Cockcroft Gault formula could not be recalculated.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
Overall Number of Participants Analyzed 1975
Median (Inter-Quartile Range)
Unit of Measure: ml/min
55.2
(43.6 to 68.3)
Time Frame One single observation time point: at the time of prescription before the first intake of dabigatran etexilate
Adverse Event Reporting Description Patients were documented at the time of the first prescription of dabigatran etexilate within the study period and before the first intake of Pradaxa®.
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   0/0 
This non-interventional studies is conducted according to §67, section 6 German Medicines Act. The term ‚principal investigator‘ is not applicable.
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
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