ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study

Conditions

Acute Coronary Syndrome

Keywords

stent, percutaneous coronary transluminal angioplasty, bleeding, antiplatelet agents

Brief 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.

Detailed description

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.

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.

2025-11-13

10.1016/j.jacasi.2025.09.015

Aspirin Versus Clopidogrel Beyond 1 Month After PCI in Patients With Oral Anticoagulation

Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto, Yuki Obayashi et al. (23 authors)

Circulation Cardiovascular Interventions2025-09-242 citations

10.1161/circinterventions.125.015495

Aspirin vs Clopidogrel 1 Month After Acute Coronary Syndrome With High-Bleeding Risk or ST-Segment Elevation.

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.

2025-06-041 citations

10.1016/j.jcin.2025.03.029

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

Tetsuya Ishikawa, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto et al. (22 authors)

Circulation Cardiovascular Interventions2025-05-143 citations

10.1161/circinterventions.124.015197

Aspirin vs. clopidogrel monotherapy beyond 1 month after complex percutaneous coronary intervention: a pre-specified subgroup analysis of the STOPDAPT-3 trial

Takenori Domei, Ko Yamamoto, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto et al. (24 authors)

European Heart Journal - Cardiovascular Pharmacotherapy2025-01-25

10.1093/ehjcvp/pvaf002

Aspirin vs. clopidogrel monotherapy after percutaneous coronary intervention: 1-year follow-up of the STOPDAPT-3 trial

Hirotoshi Watanabe, Masahiro Natsuaki, Takeshi Morimoto, Ko Yamamoto, Yuki Obayashi et al. (27 authors)

European Heart Journal2024-08-3127 citations

10.1093/eurheartj/ehae617

Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial.

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.

2024-07-062 citations

10.1016/j.amjcard.2024.07.002

An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.

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.

2024-05-015 citations

10.1016/j.jcin.2024.03.017

An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial

Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto, Yuki Obayashi et al. (26 authors)

Circulation2023-11-23120 citations

10.1161/circulationaha.123.066720

Interventions

DRUGNo aspirin

1-month prasugrel monotherapy followed by clopidogrel monotherapy

DRUG1-month DAPT

1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Patients who are planned to have percutaneous coronary intervention with exclusive use of everolimus-eluting stent (XienceTM series). * 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 who are judged to be unsuitable for participation by the principal investigator and co-investigator * Patients with a known allergy to the study drugs * Patients enrolled in the ongoing prospective interventional studies

Design outcomes

Primary

Measure	Time frame	Description
Major bleeding	1 month	Bleeding defined as BARC criteria 3 or 5
Cardiovascular composite endpoint	1 month	Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis

Secondary

Measure	Time frame	Description
Myocardial infarction	1 month	Defined by arterial revascularization therapies study (ARTS) criteria
Stroke	1 month	Including both ischemic and hemorrhagic stroke
Ischemic stroke	1 month	Ischemic stroke with symptom lasting over 24 hours
Hemorrhagic stroke	1 month	Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
Stent thrombosis	1 month	Stent thrombosis defined by Academic Research Consortium definition
Target lesion failure	1 month	The angiographical confirmation of the restenosis of the target lesions
Target vessel failure	1 month	The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels
Any target lesion revascularization	1 month	Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting
Clinically-driven target lesion revascularization	1 month	Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Non-target lesions revascularization	1 month	Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
Coronary artery bypass grafting	1 month	Any coronary artery bypass grafting
Any target vessel revascularization	1 month	Revascularization to the target vessel
Any coronary revascularization	1 month	Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
Death	1 month	Death from any cause
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria	1 month	Type 3 bleeding defined by BARC criteria
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria	1 month	Type 4 bleeding defined by BARC criteria
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	1 month	Type 5 bleeding defined by BARC criteria
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	1 month	Type 2, 3, or 5 bleeding defined by BARC criteria
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	1 month	Major bleeding defined by TIMI criteria
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	1 month	Minor bleeding defined by TIMI criteria
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	1 month	Major or minor defined by TIMI criteria
Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	1 month	Severe bleeding defined by GUSTO criteria
Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	1 month	Moderate bleeding defined by GUSTO criteria
Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	1 month	Moderate or severe bleeding defined by GUSTO criteria
Intracranial bleeding	1 month	Intracranial bleeding regardless of spontaneous or trauma
Gastrointestinal bleeding	1 month	Bleeding from gastrointestinal tract regardless of severity
Gastrointestinal complaints	1 month	Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria	1 month	Type 2 bleeding defined by BARC criteria
Cardiovascular death	1 month	Death from cardiac or vascular disease

Countries

Japan

Outcome results

None listed