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

Yonsei University1 site in 1 country3,488 target enrollmentAugust 2021

ConditionsHigh Ischemic Risk

InterventionsTicagrelor-based dual-antiplatelet therapy Clopidogrel-based dual-antiplatelet therapy

DrugsTicagrelor-based dual-antiplatelet therapy Clopidogrel-based dual-antiplatelet therapy

Overview

Phase: Not Applicable
Intervention: Ticagrelor-based dual-antiplatelet therapy
Conditions: High Ischemic Risk
Sponsor: Yonsei University
Enrollment: 3488
Locations: 1
Primary Endpoint: Composite of all-cause death, myocardial infarction, or stroke
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2021

End Date

June 2026

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥50 years old
•History of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago
•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

•Age ≥85 years old
•Pregnant women or women with potential childbearing
•Life expectancy \< 1 year
•Inability to understand or read the informed consent
•Need for long-term anticoagulation therapy

Arms & Interventions

Ticagrelor-based dual-antiplatelet therapy

Aspirin with ticagrelor

Intervention: Ticagrelor-based dual-antiplatelet therapy

Clopidogrel-based dual-antiplatelet therapy

Aspirin with clopidogrel

Intervention: Clopidogrel-based dual-antiplatelet therapy

Outcomes

Primary Outcomes

Composite of all-cause death, myocardial infarction, or stroke

Time Frame: up to 24 months

Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization

Secondary Outcomes

Stroke(up to 24 months)
Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding(up to 24 months)
Cardiac death(up to 24 months)
BARC type 2, 3, or 5 bleeding(up to 24 months)
All-cause death(up to 24 months)
Myocardial infarction(up to 24 months)