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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.
In the previous trial, 1-month dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy provided a net clinical benefit for the cardiovascular and bleeding events over 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. However, even with very short DAPT, the rate of bleeding at 1-year remained very high in other trials that enrolled the patients with high bleeding risk (HBR). Notably, the risk of bleeding in patients with high bleeding risk (HBR) was particularly high within 1-month after percutaneous coronary intervention (PCI) in previous cohort data, when DAPT is implemented even in very short DAPT regimen. More recently, in another trial, prasugrel monotherapy without aspirin immediately after successful stent implantation was associated with no stent thrombosis in selected patients with low risk stable coronary artery disease. Aspirin-free strategy might be particularly beneficial in reducing bleeding in HBR patients. Patients with acute coronary syndrome (ACS) are also reported to be associated with higher risk for bleeding.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No aspirin | Active Comparator | To start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI. |
|
| 1-month DAPT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No aspirin | Drug | 1-month prasugrel monotherapy followed by clopidogrel monotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | Bleeding defined as BARC criteria 3 or 5 | 1 month |
| Cardiovascular composite endpoint | Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death from any cause | 1 month |
| Death | Death from any cause | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Kimura, MD | Kyoto University, Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Graduate School of Medicine | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41307518 | Derived | 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. | |
| 40988628 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C488176 | N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester |
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
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| 1-month DAPT |
| Drug |
1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy |
|
| Cardiovascular death | Death from cardiac or vascular disease | 1 month |
| Cardiovascular death | Death from cardiac or vascular disease | 12 months |
| Myocardial infarction | Defined by arterial revascularization therapies study (ARTS) criteria | 1 month |
| Myocardial infarction | Defined by arterial revascularization therapies study (ARTS) criteria | 12 months |
| Stroke | Including both ischemic and hemorrhagic stroke | 1 month |
| Stroke | Including both ischemic and hemorrhagic stroke | 12 months |
| Ischemic stroke | Ischemic stroke with symptom lasting over 24 hours | 1 month |
| Ischemic stroke | Ischemic stroke with symptom lasting over 24 hours | 12 months |
| Hemorrhagic stroke | Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma | 1 month |
| Hemorrhagic stroke | Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma | 12 months |
| Stent thrombosis | Stent thrombosis defined by Academic Research Consortium definition | 1 month |
| Stent thrombosis | Stent thrombosis defined by Academic Research Consortium definition | 12 months |
| Target lesion failure | The angiographical confirmation of the restenosis of the target lesions | 1 month |
| Target lesion failure | The angiographical confirmation of the restenosis of the target lesions | 12 months |
| Target vessel failure | The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels | 1 month |
| Target vessel failure | The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels | 12 months |
| Any target lesion revascularization | Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting | 1 month |
| Any target lesion revascularization | Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting | 12 months |
| Clinically-driven target lesion revascularization | Target lesion revascularization with the anginal symptoms or the positive test for ischemia | 1 month |
| Clinically-driven target lesion revascularization | Target lesion revascularization with the anginal symptoms or the positive test for ischemia | 12 months |
| Non-target lesions revascularization | Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting | 1 month |
| Non-target lesions revascularization | Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting | 12 months |
| Coronary artery bypass grafting | Any coronary artery bypass grafting | 1 month |
| Coronary artery bypass grafting | Any coronary artery bypass grafting | 12 months |
| Any target vessel revascularization | Revascularization to the target vessel | 1 month |
| Any target vessel revascularization | Revascularization to the target vessel | 12 months |
| Any coronary revascularization | Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting | 1 month |
| Any coronary revascularization | Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting | 12 months |
| Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2 bleeding defined by BARC criteria | 1 month |
| Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2 bleeding defined by BARC criteria | 12 months |
| Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 3 bleeding defined by BARC criteria | 1 month |
| Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 3 bleeding defined by BARC criteria | 12 months |
| Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 4 bleeding defined by BARC criteria | 1 month |
| Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 4 bleeding defined by BARC criteria | 12 months |
| Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 5 bleeding defined by BARC criteria | 1 month |
| Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 5 bleeding defined by BARC criteria | 12 months |
| Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2, 3, or 5 bleeding defined by BARC criteria | 1 month |
| Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria | Type 2, 3, or 5 bleeding defined by BARC criteria | 12 months |
| Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major bleeding defined by TIMI criteria | 1 month |
| Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major bleeding defined by TIMI criteria | 12 months |
| Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Minor bleeding defined by TIMI criteria | 1 month |
| Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Minor bleeding defined by TIMI criteria | 12 months |
| Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major or minor defined by TIMI criteria | 1 month |
| Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria | Major or minor defined by TIMI criteria | 12 months |
| Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Severe bleeding defined by GUSTO criteria | 1 month |
| Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Severe bleeding defined by GUSTO criteria | 12 months |
| Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Moderate bleeding defined by GUSTO criteria | 1 month |
| Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Moderate bleeding defined by GUSTO criteria | 12 months |
| Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Moderate or severe bleeding defined by GUSTO criteria | 1 month |
| Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria | Moderate or severe bleeding defined by GUSTO criteria | 12 months |
| Intracranial bleeding | Intracranial bleeding regardless of spontaneous or trauma | 1 month |
| Intracranial bleeding | Intracranial bleeding regardless of spontaneous or trauma | 12 months |
| Gastrointestinal bleeding | Bleeding from gastrointestinal tract regardless of severity | 1 month |
| Gastrointestinal bleeding | Bleeding from gastrointestinal tract regardless of severity | 12 months |
| Gastrointestinal complaints | Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints | 1 month |
| Gastrointestinal complaints | Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints | 12 months |
| Derived |
| 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. |
| 40471776 | Derived | 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. |
| 40365675 | Derived | 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. |
| 39863419 | Derived | 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. |
| 39215959 | Derived | 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. |
| 38972535 | Derived | 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. |
| 38749592 | Derived | 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. |
| 37994553 | Derived | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |