3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI

NCT ID: NCT04570345

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1002 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the clinical outcomes of dual antiplatelet therapy with aspirin and P2Y12 receptor inhibitor vs. ticagrelor monotherapy at 3 months after PCI in patients with ST-elevation myocardial infarction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to compare the use of ticagrelor alone versus P2Y12 receptor inhibitor and aspirin together after PCI among ST-elevation myocardial infarction patients who complete 3-month course of dual antiplatelet therapy. The object of this study is to determine the effectiveness and safety of ticagrelor alone, compared to P2Y12 receptor inhibitor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among patients diagnosed with ST-elevation myocardial infarction undergoing PCI with second-generation drug-eluting stent.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ST Elevation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ticagrelor monotherapy

Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor)

Group Type EXPERIMENTAL

ticagrelor monotherapy

Intervention Type DRUG

• Drug: ticagrelor monothearpy after first 3 months dual therapy

Aspirin with P2Y12 receptor inhibitor

Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor)

Group Type ACTIVE_COMPARATOR

ticagrelor monotherapy

Intervention Type DRUG

• Drug: ticagrelor monothearpy after first 3 months dual therapy

Aspirin with P2Y12 receptor inhibitor

Intervention Type DRUG

• Drug: aspirin plus ticagrelor dual therapy during 12 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ticagrelor monotherapy

• Drug: ticagrelor monothearpy after first 3 months dual therapy

Intervention Type DRUG

Aspirin with P2Y12 receptor inhibitor

• Drug: aspirin plus ticagrelor dual therapy during 12 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Study group Control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients ≥ 19 years old
* Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS
* Provision of informed consent

Exclusion Criteria

* Age \> 80 years
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dong-A University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kyungil Park

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kyungil Park, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Internal Medicine,Dong-A University College of Medicine

Busan, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kyungil Park, Ph.D

Role: CONTACT

Phone: 82-51-240-2733

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kyungil Park, MD

Role: primary

YoungRak Cho, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DAUHIRB-20-162

Identifier Type: -

Identifier Source: org_study_id