N/A
N=2,120
Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01721837 ↗Enrolled (actual)
2,120
Serious AEs
—
Results posted
Jul 2014
Primary outcome: Primary: Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) — 55.2 ml/min
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) |
55.2 | — |
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
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01721837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.