24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial

NCT ID: NCT04989257

Last Updated: 2021-08-04

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

3488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this prospective randomized clinical trial is to compare the clinical outcomes between aspirin with ticagrelor versus aspirin with clopidogrel in high ischemic risk patients beyond 12 months after percutaneous coronary intervention with drug-eluting stent implantation

Detailed Description

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Conditions

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High Ischemic Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor-based dual-antiplatelet therapy

Aspirin with ticagrelor

Group Type EXPERIMENTAL

Ticagrelor-based dual-antiplatelet therapy

Intervention Type DRUG

Aspirin with ticagrelor

Clopidogrel-based dual-antiplatelet therapy

Aspirin with clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel-based dual-antiplatelet therapy

Intervention Type DRUG

Aspirin with clopidogrel

Interventions

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Ticagrelor-based dual-antiplatelet therapy

Aspirin with ticagrelor

Intervention Type DRUG

Clopidogrel-based dual-antiplatelet therapy

Aspirin with clopidogrel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥50 years old
2. History of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago
3. High-risk for ischemic events (at least one of the following) 1) Age \>65 years old 2) Medical treatments for diabetes mellitus 3) Multi-vessel coronary artery disease 4) More than 2 episodes of myocardial infarction 5) Chronic kidney disease (stage III or IV)

Exclusion Criteria

1. Age ≥85 years old
2. Pregnant women or women with potential childbearing
3. Life expectancy \< 1 year
4. Inability to understand or read the informed consent
5. Need for long-term anticoagulation therapy
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Byeong-Keuk Kim

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Byeong-Keuk Kim

Role: CONTACT

82-2-2228-8460

Facility Contacts

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Byeong-Keuk Kim

Role: primary

82-2-2228-8460

Other Identifiers

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4-2021-0591

Identifier Type: -

Identifier Source: org_study_id

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