drugset / Trial / NCT03062319
Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis
Phase 4
Terminated
321 enrolled
National Hospital Organization Osaka National Hospital
Network for Clinical Stroke Trials · collabThe BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis.
Timeline
- Start
- 2017-04-06
- Primary completion
- 2023-07-18
- Completion
- 2023-07-18
Publications
- Okazaki S, Tanaka K, Yazawa Y, Doijiri R, Koga M, Ihara M, Yamamoto S, Kamiyama K, Honda Y, Uchida K, Yoshimoto T, Asakura K, Omae K, Tanaka K, Maeda H, Yamamoto H, Hirano T, Toyoda K, Iguchi Y, Noguchi T, Okada Y, Kitagawa K, Sakai N, Yamagami H; ATIS-NVAF Trial Investigators. Optimal Antithrombotics for Ischemic Stroke and Concurrent Atrial Fibrillation and Atherosclerosis: A Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1227-1234. doi: 10.1001/jamaneurol.2025.3662.
- Okazaki S, Yamamoto H, Asakura K, Omae K, Maeda H, Tanaka K, Yamamoto S, Hirano T, Iguchi Y, Sakaguchi M, Koga M, Ihara M, Toyoda K, Noguchi T, Sakai N, Yamagami H. Optimal antithrombotic therapy in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis: study protocol for a randomized controlled trial. Front Neurol. 2024 Oct 23;15:1468523. doi: 10.3389/fneur.2024.1468523. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Apixaban | Small molecule | — | Oral |
| Comparator | Aspirin | Small molecule | — | — |
| Comparator | Cilostazol | Small molecule | — | — |
| Comparator | Clopidogrel | Small molecule | — | — |
| Comparator | Dabigatran | Unknown | — | Oral |
| Comparator | Edoxaban | Small molecule | — | Oral |
| Comparator | Prasugrel | Small molecule | — | — |
| Comparator | Rivaroxaban | Other / unclassified | — | Oral |
| Comparator | Warfarin | Small molecule | — | Oral |
| Comparator | ticlopidine | Small molecule | — | — |