Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF
Summary
This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.
Timeline
- Start
- 2026-06-01
- Primary completion
- 2029-06-01
- Completion
- 2029-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | — | Oral |
| Subject | Dabigatran | Unknown | — | Oral |
| Subject | Edoxaban | Small molecule | — | Oral |
| Subject | Rivaroxaban | Other / unclassified | — | Oral |
| Comparator | Aspirin | Small molecule | — | — |
| Comparator | Clopidogrel | Small molecule | — | — |