ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study
NCT ID: NCT04609111
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
6002 participants
INTERVENTIONAL
2021-01-29
2025-12-31
Brief Summary
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Detailed Description
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Therefore, we have planned a study to compare the cardiovascular and bleeding events at 1-month after PCI using CoCr-EES between no DAPT strategy and 1-month DAPT strategy in patients with HBR or ACS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No aspirin
To start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI.
No aspirin
1-month prasugrel monotherapy followed by clopidogrel monotherapy
1-month DAPT
To start dual antiplatelet therapy comprising of aspirin and prasugrel before the index percutaneous coronary intervention (PCI) and to change into aspirin monotherapy at 1-month after the PCI.
1-month DAPT
1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy
Interventions
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No aspirin
1-month prasugrel monotherapy followed by clopidogrel monotherapy
1-month DAPT
1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy
Eligibility Criteria
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Inclusion Criteria
* Patients with high bleeding risk defined by Academic Research Consortium or acute coronary syndrome
* Patients who could take dual antiplatelet therapy with aspirin and P2Y12 inhibitors for 1-month
Exclusion Criteria
* Patients with a known allergy to the study drugs
* Patients enrolled in the ongoing prospective interventional studies
ALL
No
Sponsors
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Kyoto University, Graduate School of Medicine
OTHER
Responsible Party
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Takeshi Morimoto
Study Statistician
Principal Investigators
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Takeshi Kimura, MD
Role: PRINCIPAL_INVESTIGATOR
Kyoto University, Graduate School of Medicine
Locations
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Kyoto University Graduate School of Medicine
Kyoto, , Japan
Countries
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References
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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 Sep 24:e015495. doi: 10.1161/CIRCINTERVENTIONS.125.015495. Online ahead of print.
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.
Other Identifiers
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Y0080
Identifier Type: -
Identifier Source: org_study_id
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