Trial Outcomes & Findings for Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment (NCT NCT01721837)

Results Overview

The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.

Recruitment status

COMPLETED

Target enrollment

4340 participants

Primary outcome timeframe

One single observation time point: at the time of prescription before the first intake of dabigatran etexilate

Results posted on

2014-07-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	All Patients All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).
Overall Study STARTED	2120
Overall Study COMPLETED	2120
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=2120 Participants All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
Age, Continuous	75.2 years STANDARD_DEVIATION 8.8 • n=5 Participants
Gender Female	1015 participants n=5 Participants
Gender Male	1101 participants n=5 Participants

PRIMARY outcome

Timeframe: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate

Population: 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.

The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.

Outcome measures

Outcome measures
Measure	All Patients n=1975 Participants All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)	55.2 ml/min Interval 43.6 to 68.3

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place