NCT05320926

Brief Summary

Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,744

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress63%
Jul 2022Jul 2028

First Submitted

Initial submission to the registry

April 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 26, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2028

Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

6 years

First QC Date

April 3, 2022

Last Update Submit

October 21, 2024

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Net adverse clinical events (NACE)

    Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5)

    1 year after the procedure

Secondary Outcomes (6)

  • Each component of NACE

    1 year after the procedure

  • Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke)

    1 year after the procedure

  • Cardiac death

    1 year after the procedure

  • Stent thrombosis (definite or probable)

    1 year after the procedure

  • Target-vessel revascularization

    1 year after the procedure

  • +1 more secondary outcomes

Study Arms (2)

Short-term DAPT followed by clopidogrel monotherapy

EXPERIMENTAL

atients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop aspirin and maintain clopidogrel after DAPT.

Drug: Clopidogrel monotherapyDevice: zotarolimus-eluting stent (Resolute Onyx ®)

Short-term DAPT followed by aspirin monotherapy

ACTIVE COMPARATOR

Arm Description: Patients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop clopidogrel and maintain aspirin after DAPT.

Drug: Aspirin monotherapyDevice: zotarolimus-eluting stent (Resolute Onyx ®)

Interventions

Clopidogrel monotherapyDRUG

Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.

Short-term DAPT followed by clopidogrel monotherapy
Aspirin monotherapyDRUG

Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.

Short-term DAPT followed by aspirin monotherapy
zotarolimus-eluting stent (Resolute Onyx ®)DEVICE

zotarolimus-eluting stent (Resolute Onyx ®)

Short-term DAPT followed by aspirin monotherapyShort-term DAPT followed by clopidogrel monotherapy

Eligibility Criteria

Age19 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥19 years
  • Patients who received new generation zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease
  • Provision of informed consent

You may not qualify if:

  • Age ≥ 85 years
  • Acute myocardial infarction
  • \. Left main bifurcation requiring 2-stent technique 3. Pregnant women or women with potential childbearing 4. Life expectancy \< 1 year 5. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 6. Inability to understand or read the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Byeong-Keuk Kim

    Severance Cardiovascular Hospital, Yonsei University Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Byeong-Keuk Kim

CONTACT

82-2228-8460kimbk@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2022

First Posted

April 11, 2022

Study Start

July 26, 2022

Primary Completion (Estimated)

July 10, 2028

Study Completion (Estimated)

July 10, 2028

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)