drugset / Trial / NCT04609111
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to explore the benefit of the prasugrel monotherapy without aspirin as compared with the 1-month dual therapy with aspirin and prasugrel in terms of reducing bleeding events after percutaneous coronary intervention (PCI) using cobalt-chromium everolimus-eluting stents (CoCr-EES, XienceTM) in patients with high bleeding risk or under the acute coronary syndrome patients.
Timeline
- Start
- 2021-01-29
- Primary completion
- 2023-12-31
- Completion
- 2025-12-31
Publications
- Nishikura T, Yamamoto K, Wakabayashi K, Natsuaki M, Watanabe H, Morimoto T, Obayashi Y, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Onishi Y, Hibi K, Kawai K, Murakami T, Takasaki A, Higashitani N, Nakano M, Ono K, Kimura T; STOPDAPT-3 investigators. Effect of Proton Pump Inhibitors in Patients Undergoing Percutaneous Coronary Intervention With Aspirin-Free Strategy. JACC Asia. 2026 Feb;6(2):128-140. doi: 10.1016/j.jacasi.2025.09.015. Epub 2025 Nov 26.
- Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tamura T, Kawahatsu K, Hayashi F, Akao M, Serikawa T, Mori H, Kawamura T, Hagikura A, Shibata N, Ono K, Kimura T. Aspirin Versus Clopidogrel Beyond 1 Month After PCI in Patients With Oral Anticoagulation. Circ Cardiovasc Interv. 2025 Nov;18(11):e015495. doi: 10.1161/CIRCINTERVENTIONS.125.015495. Epub 2025 Sep 24.
- Obayashi Y, Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tokuyama H, Sakamoto H, Fujita T, Nanasato M, Okayama H, Nishikura T, Kirigaya H, Nishida K, Ono K, Kimura T; STOPDAPT-3 Investigators. Aspirin vs Clopidogrel 1 Month After Acute Coronary Syndrome With High-Bleeding Risk or ST-Segment Elevation. JACC Cardiovasc Interv. 2025 Sep 8;18(17):2120-2135. doi: 10.1016/j.jcin.2025.03.029. Epub 2025 Jun 4.
- Ishikawa T, Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Ando K, Suwa S, Isawa T, Takenaka H, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Hojo S, Tsutsumi J, Yamamoto H, Ueda H, Ono K, Kimura T. Aspirin-Free Strategy for PCI in Patients With High Bleeding Risk With or Without Acute Coronary Syndrome: A Subgroup Analysis From the STOPDAPT-3 Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015197. doi: 10.1161/CIRCINTERVENTIONS.124.015197. Epub 2025 May 14.
- Domei T, Yamamoto K, Natsuaki M, Watanabe H, Morimoto T, Obayashi Y, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tamura T, Kawahatsu K, Hayashi F, Abe M, Serikawa T, Mori H, Kawamura T, Hagikura A, Shibata N, Ono K, Kimura T. Aspirin vs. clopidogrel monotherapy beyond 1 month after complex percutaneous coronary intervention: a pre-specified subgroup analysis of the STOPDAPT-3 trial. Eur Heart J Cardiovasc Pharmacother. 2025 Mar 13;11(2):198-209. doi: 10.1093/ehjcvp/pvaf002.
- Watanabe H, Natsuaki M, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Ando K, Domei T, Suwa S, Ogita M, Isawa T, Takenaka H, Yamamoto T, Ishikawa T, Hisauchi I, Wakabayashi K, Onishi Y, Hibi K, Kawai K, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Ono K, Kimura T. Aspirin vs. clopidogrel monotherapy after percutaneous coronary intervention: 1-year follow-up of the STOPDAPT-3 trial. Eur Heart J. 2024 Dec 16;45(47):5042-5054. doi: 10.1093/eurheartj/ehae617.
- Watanabe H, Natsuaki M, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Hamatani Y, Ando K, Domei T, Suwa S, Ogita M, Isawa T, Takenaka H, Yamamoto T, Ishikawa T, Hisauchi I, Wakabayashi K, Onishi Y, Hibi K, Kawai K, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Ono K, Kimura T; STOPDAPT-3 Investigators. Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial. Am J Cardiol. 2024 Sep 1;226:83-96. doi: 10.1016/j.amjcard.2024.07.002. Epub 2024 Jul 6.
- Yamamoto K, Natsuaki M, Watanabe H, Morimoto T, Obayashi Y, Nishikawa R, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tamura T, Kawahatsu K, Hayashi F, Akao M, Serikawa T, Mori H, Kawamura T, Hagikura A, Shibata N, Ono K, Kimura T; STOPDAPT-3 Investigators. An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2024 May 13;17(9):1119-1130. doi: 10.1016/j.jcin.2024.03.017.
- Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Ando K, Domei T, Suwa S, Ogita M, Isawa T, Takenaka H, Yamamoto T, Ishikawa T, Hisauchi I, Wakabayashi K, Onishi Y, Hibi K, Kawai K, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Ono K, Kimura T. An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial. Circulation. 2024 Feb 20;149(8):585-600. doi: 10.1161/CIRCULATIONAHA.123.066720. Epub 2023 Nov 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 81 mg | — |
| Comparator | Aspirin | Small molecule | 100 mg | — |
| Comparator | Clopidogrel | Small molecule | — | — |
| Comparator | Prasugrel | Small molecule | 3.75 mg | — |