NCT04609111

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,002

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

October 23, 2020

Last Update Submit

June 12, 2024

Conditions

Acute Coronary Syndrome

Keywords

stentpercutaneous coronary transluminal angioplastybleedingantiplatelet agents

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (58)

  • Death

    1 month

  • Death

    12 months

  • Cardiovascular death

    1 month

  • Cardiovascular death

    12 months

  • Myocardial infarction

    1 month

  • +53 more secondary outcomes

Study Arms (2)

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.

Drug: No aspirin

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.

Drug: 1-month DAPT

Interventions

No aspirinDRUG

1-month prasugrel monotherapy followed by clopidogrel monotherapy

No aspirin
1-month DAPTDRUG

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

1-month DAPT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Graduate School of Medicine

Kyoto, 606-8507, Japan

Location

Related Publications (9)

  • 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. 2025 Nov 13:S2772-3747(25)00542-3. doi: 10.1016/j.jacasi.2025.09.015. Online ahead of print.

    PMID: 41307518DERIVED

  • 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.

    PMID: 40988628DERIVED

  • 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.

    PMID: 40471776DERIVED

  • 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.

    PMID: 40365675DERIVED

  • 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.

    PMID: 39863419DERIVED

  • 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.

    PMID: 39215959DERIVED

  • 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.

    PMID: 38972535DERIVED

  • 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.

    PMID: 38749592DERIVED

  • 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.

    PMID: 37994553DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeHemorrhage

Interventions

N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Takeshi Kimura, MD

    Kyoto University, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Statistician

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 30, 2020

Study Start

January 29, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)