NCT02619760

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,045

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

November 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2018

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

November 29, 2015

Last Update Submit

June 12, 2024

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary InterventionPlatelet Aggregation Inhibitors

Outcome Measures

Primary Outcomes (1)

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

    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-month

Secondary Outcomes (44)

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

    12-month

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

    60-month

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

    12-month

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

    60-month

  • Upper gastrointestinal endoscopic examination or treatment

    60-month

  • +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 , followed by 59-month clopidogrel monotherapy

Drug: 1-month DAPT

12-month DAPT

ACTIVE COMPARATOR

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists with 11-month DAPT composed of aspirin and clopidogrel, followed by 48-month aspirin monotherapy

Drug: 12-month DAPT

Interventions

1-month DAPTDRUG

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

1-month DAPT
12-month DAPTDRUG

12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

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
  • Patients who are capable of oral dual antiplatelet therapy consisting of asprin 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 (Xience) implanted at the time of enrollment
  • Patients comfirmed to have no tolerability to clopidgorel before enrollment
  • Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
  • Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Related Publications (7)

  • 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

  • Yamamoto K, Watanabe H, Morimoto T, Domei T, Ohya M, Ogita M, Takagi K, Suzuki H, Nikaido A, Ishii M, Fujii S, Natsuaki M, Yasuda S, Kaneko T, Tamura T, Tamura T, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Igarashi Hanaoka K, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight From the STOPDAPT-2 Trial. Circ Cardiovasc Interv. 2021 May;14(5):e010384. doi: 10.1161/CIRCINTERVENTIONS.120.010384. Epub 2021 May 18.

    PMID: 34003662DERIVED

  • Watanabe H, Morimoto T, Ogita M, Suwa S, Natsuaki M, Suematsu N, Koeda Y, Morino Y, Nikaido A, Hata Y, Doi M, Hibi K, Kimura K, Yoda S, Kaneko T, Nishida K, Kawai K, Yamaguchi K, Wakatsuki T, Tonoike N, Yamamoto M, Shimizu S, Shimohama T, Ako J, Kimura T; STOPDAPT-2 Investigators. Influence of CYP2C19 genotypes for the effect of 1-month dual antiplatelet therapy followed by clopidogrel monotherapy relative to 12-month dual antiplatelet therapy on clinical outcomes after percutaneous coronary intervention: a genetic substudy from the STOPDAPT-2. Cardiovasc Interv Ther. 2021 Oct;36(4):403-415. doi: 10.1007/s12928-020-00719-6. Epub 2020 Nov 12.

    PMID: 33184726DERIVED

  • Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 investigators. Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial. Cardiovasc Interv Ther. 2021 Jan;36(1):91-103. doi: 10.1007/s12928-020-00651-9. Epub 2020 Feb 21.

    PMID: 32086787DERIVED

  • Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2414-2427. doi: 10.1001/jama.2019.8145.

    PMID: 31237644DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

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

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Takeshi Kimura, MD, PhD

    Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

    STUDY CHAIR

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
Professor of Medicine

Study Record Dates

First Submitted

November 29, 2015

First Posted

December 2, 2015

Study Start

December 1, 2015

Primary Completion

December 8, 2018

Study Completion

December 31, 2023

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations

JP(1)