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

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

Study Overview

• Status: Not yet recruiting
• Conditions: High Ischemic Risk
• Intervention / Treatment: Drug: Ticagrelor-based dual-antiplatelet therapy; Drug: Clopidogrel-based dual-antiplatelet therapy

• Study Type: Interventional
• Enrollment (Anticipated): 3488
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Byeong-Keuk Kim; Phone Number: 82-2-2228-8460; Email: kimbk@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Contact: Byeong-Keuk Kim; Phone Number: 82-2-2228-8460; Email: kimbk@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ticagrelor-based dual-antiplatelet therapy; Aspirin with ticagrelor	Drug: Ticagrelor-based dual-antiplatelet therapy; Aspirin with ticagrelor
Active Comparator: Clopidogrel-based dual-antiplatelet therapy; Aspirin with clopidogrel	Drug: Clopidogrel-based dual-antiplatelet therapy; Aspirin with clopidogrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause death, myocardial infarction, or stroke	Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization	up to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Byeong-Keuk Kim, Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: 4-2021-0591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No