drugset / Trial / NCT01962545
Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study
Phase 4
Completed
690 enrolled
Satoshi Shizuta
Daiichi Sankyo · collabResearch Institute for Production Development · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate non-inferiority of oral anticoagulant (OAC) monotherapy to OAC plus single antiplatelet therapy (APT) in patients with atrial fibrillation (AF) and prior (\>12 months) coronary stenting.
Timeline
- Start
- 2013-11-05
- Primary completion
- 2017-05-18
- Completion
- 2018-05-18
Outcome
Missed primary endpoint
paper This randomized trial did not establish noninferiority of OAC alone to combined OAC and APT in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after stenting. PMID 30586700 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 81 mg | — |
| Subject | Aspirin | Small molecule | 324 mg | — |
| Subject | Clopidogrel | Small molecule | 75 mg | — |
| Background | Apixaban | Small molecule | 2.5 mg | Oral |
| Background | Apixaban | Small molecule | 5 mg | Oral |
| Background | Dabigatran | Unknown | 110 mg | Oral |
| Background | Dabigatran | Unknown | 150 mg | Oral |
| Background | Edoxaban | Small molecule | 30 mg | Oral |
| Background | Edoxaban | Small molecule | 60 mg | Oral |
| Background | Rivaroxaban | Other / unclassified | 10 mg | Oral |
| Background | Rivaroxaban | Other / unclassified | 15 mg | Oral |
| Background | Warfarin | Small molecule | — | Oral |