drugset / Trial / NCT03718273
IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study).
Phase 3
Completed
68 enrolled
Adolfo Fontenla
Carlos III Health Institute · collabSpanish Clinical Research Network - SCReN · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The BRAKE-AF Study is a phase III, randomised, controlled, multicentric, open-label clinical trial to prove the noninferiority of ivabradine versus digoxin in the treatment of permanent atrial fibrillation. The total duration of the study is 3 years, with 24 months of enrolment, treatment and follow-up.
Timeline
- Start
- 2018-10-19
- Primary completion
- 2022-02-22
- Completion
- 2022-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Digoxin | Other / unclassified | 0.1 mg | Oral |
| Comparator | Digoxin | Other / unclassified | 0.15 mg | Oral |
| Comparator | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Subject | Ivabradine | Small molecule | 7.5 mg | Oral |