Atrial Fibrillation
Conditions
Brief summary
Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention * patients with mild or moderate renal impairment * age \>= 18 years at enrollment
Exclusion criteria
\- severe renal impairment (Creatinine Clearance \< 30 ml/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) | One single observation time point: at the time of prescription before the first intake of dabigatran etexilate | The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine. |
Countries
Germany
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS). | 2,120 |
| Total | 2,120 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 75.2 years STANDARD_DEVIATION 8.8 |
| Gender Female | 1015 participants |
| Gender Male | 1101 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) | 55.2 ml/min |