NCT05770674

Brief Summary

This study is a prospective, open-label, multicenter, randomized clinical trial to evaluate the efficacy of 1 month dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel followed by clopidogrel monotherapy, compared with 12 months DAPT with aspirin plus clopidogrel in patients undergoing percutaneous coronary intervention with Genoss® drug eluting stents.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,186

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
10 months 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

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 5, 2023

Last Update Submit

March 5, 2023

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary InterventionDual Antiplatelet TherapyDrug Eluting Stent

Outcome Measures

Primary Outcomes (1)

  • NACE (Net Adverse Clinical Event)

    A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, definite stent thrombosis, or BARC (Bleeding Academic Research Consortium) type 3 or 5 bleeding events

    12 Months

Secondary Outcomes (11)

  • MACE (Major Adverse Cardiovascular Events)

    12 Months

  • BARC Type 3 / 5 bleeding events

    12 Months

  • All cause death

    12 Months

  • Cardiovascular death

    12 Months

  • Myocardial infarction

    12 Months

  • +6 more secondary outcomes

Study Arms (2)

1 Month DAPT

ACTIVE COMPARATOR

Patients will receive 300 mg of aspirin and 300 mg of clopidogrel before PCI unless previously medicated with antiplatelet agents. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for 1 month following PCI. Following 1 month, clopidogrel 75 mg once daily will be given for 11 months.

Drug: 1 Month vs. 12 Months DAPT

12 Months DAPT

ACTIVE COMPARATOR

Patients will receive 300 mg of aspirin and 300 mg of clopidogrel before PCI unless previously medicated with antiplatelet agents. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for 12 months following PCI.

Drug: 1 Month vs. 12 Months DAPT

Interventions

1 Month vs. 12 Months DAPTDRUG

Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation 1. 1 Month following PCI, followed by clopidogrel monotherapy 2. 12 Months following PCI

1 Month DAPT12 Months DAPT

Eligibility Criteria

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

You may qualify if:

  • Subjects must be at least 19 years of age
  • Subjects undergoing elective PCI with Genoss® Drug Eluting Stents
  • Subject who can understand the risk, benefit and treatment alternatives, and when he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

You may not qualify if:

  • Subjects presenting with acute myocardial infarction
  • Subjects with less than 1 year of life expectancy
  • Subjects presenting with cardiogenic shock
  • Subjects requiring anticoagulation (warfarin, direct oral anticoagulant), or those requiring antiplatelet agents other than aspirin and P2Y12 inhibitors.
  • Subjects with history of intracranial hemorrhage (ICH)
  • Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel), or drugs used in the procedure (heparin, contrast media, sirolimus). Those with contrast hypersensitivity can be enrolled if symptom/signs can be controlled by anti-histamines or steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

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

  • Kiyuk Chang

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 15, 2023

Study Start

April 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

KR(1)