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 University

Status: Not yet enrolling

Conditions: High Ischemic Risk

Treatments: Drug: Clopidogrel-based dual-antiplatelet therapy; Drug: Ticagrelor-based dual-antiplatelet therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04989257

4-2021-0591

Details and patient eligibility

About

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

Enrollment: 3,488 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,488 participants in 2 patient groups

Ticagrelor-based dual-antiplatelet therapy

Experimental group

Description:

Aspirin with ticagrelor

Treatment:

Drug: Ticagrelor-based dual-antiplatelet therapy

Clopidogrel-based dual-antiplatelet therapy

Active Comparator group

Description:

Aspirin with clopidogrel

Treatment:

Drug: Clopidogrel-based dual-antiplatelet therapy