NCT03462498

Brief Summary

The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES) under the setting of acute coronary syndrome (ACS).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,008

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2018

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

March 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

3.8 years

First QC Date

March 6, 2018

Last Update Submit

June 12, 2024

Conditions

Acute Coronary SyndromeAcute Myocardial InfarctionCoronary Artery DiseasePercutaneous Coronary InterventionPlatelet Aggregation Inhibitors

Keywords

Acute Coronary SyndromeAcute Myocardial InfarctionCoronary Artery DiseasePercutaneous Coronary InterventionPlatelet Aggregation Inhibitors

Outcome Measures

Primary Outcomes (2)

  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    12 months

  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    60 months

Secondary Outcomes (44)

  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke

    12 months

  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke

    60 months

  • Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    12 months

  • Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    60 months

  • Upper gastrointestinal endoscopic examination or treatment

    60 months

  • +39 more secondary outcomes

Study Arms (2)

1-month DAPT

ACTIVE COMPARATOR

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months

Drug: 1-months DAPT

12-month DAPT

ACTIVE COMPARATOR

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists; 11-month DAPT composed of aspirin and clopidogrel and aspirin monotherapy for 48 months

Drug: 12-month DAPT

Interventions

1-months DAPTDRUG

1-month DAPT followed by 59-month monotherapy

1-month DAPT
12-month DAPTDRUG

12-month DAPT followed by 48-month monotherapy

12-month DAPT

Eligibility Criteria

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

You may qualify if:

  • Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent under the setting of acute coronary syndrome
  • Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and P2Y12 receptor antagonist

You may not qualify if:

  • Patients requiring oral anticoagulants
  • Patients with medical history of intracranial hemorrhage
  • Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
  • Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents implanted at the time of enrollment
  • Patients confirmed to have no tolerability to clopidogrel before enrollment
  • Patients requiring continuous administration of antiplatelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment

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 (4)

  • Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month DAPT in Patients With High Bleeding Risk or Complex PCI. JACC Asia. 2023 Jan 10;3(1):31-46. doi: 10.1016/j.jacasi.2022.09.011. eCollection 2023 Feb.

    PMID: 36873770DERIVED

  • Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, Natsuaki M, Yamaji K, Domei T, Ogita M, Ohya M, Tatsushima S, Suzuki H, Tada T, Ishii M, Nikaido A, Watanabe N, Fujii S, Mori H, Nishikura T, Suematsu N, Hayashi F, Komiyama K, Shigematsu T, Isawa T, Suwa S, Ando K, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Jan 9;16(1):19-31. doi: 10.1016/j.jcin.2022.09.053. Epub 2022 Dec 14.

    PMID: 36599584DERIVED

  • Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2022 Aug;15(8):e012004. doi: 10.1161/CIRCINTERVENTIONS.122.012004. Epub 2022 Aug 1.

    PMID: 35912647DERIVED

  • Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 ACS Investigators. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):407-417. doi: 10.1001/jamacardio.2021.5244.

    PMID: 35234821DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Takeshi Kimura, MD

    Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 12, 2018

Study Start

April 2, 2018

Primary Completion

December 31, 2021

Study Completion

March 31, 2026

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)