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

Not Applicable

Not yet recruiting

• Conditions: High Ischemic Risk
• Interventions: Drug: Ticagrelor-based dual-antiplatelet therapy; Drug: Clopidogrel-based dual-antiplatelet therapy

• Registration Number: NCT04989257
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-01
• Status Verified: 2021-08
• Study Start: 2021-08
• Study First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3488

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor-based dual-antiplatelet therapy	Ticagrelor-based dual-antiplatelet therapy	Aspirin with ticagrelor
Clopidogrel-based dual-antiplatelet therapy	Clopidogrel-based dual-antiplatelet therapy	Aspirin with clopidogrel

Primary Outcome Measures

Name	Time	Method
Composite of all-cause death, myocardial infarction, or stroke	up to 24 months	Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization

Secondary Outcome Measures

Name	Time	Method
Stroke	up to 24 months	Stroke at 24 months after randomization
Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding	up to 24 months	Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding at 24 months after randomization
Cardiac death	up to 24 months	Cardiac death at 24 months after randomization
BARC type 2, 3, or 5 bleeding	up to 24 months	BARC type 2, 3, or 5 bleeding at 24 months after randomization
All-cause death	up to 24 months	All-cause death at 24 months after randomization
Myocardial infarction	up to 24 months	Myocardial infarction at 24 months after randomization

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of