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 University3,488 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

3,488

Conditions

High Ischemic Risk

Interventions

Ticagrelor-based dual-antiplatelet therapyDRUG

Aspirin with ticagrelor

Clopidogrel-based dual-antiplatelet therapyDRUG

Aspirin with clopidogrel

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Outcomes

Primary Outcomes

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

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

Time frame: up to 24 months

Secondary Outcomes

BARC type 2, 3, or 5 bleeding

BARC type 2, 3, or 5 bleeding at 24 months after randomization

Time frame: up to 24 months

All-cause death

All-cause death at 24 months after randomization

Time frame: up to 24 months

Myocardial infarction

Myocardial infarction at 24 months after randomization

Time frame: up to 24 months

Stroke

Stroke at 24 months after randomization

Time frame: up to 24 months

Cardiac death

Cardiac death at 24 months after randomization

Time frame: 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

Time frame: up to 24 months

Central Contacts

Byeong-Keuk Kim

CONTACT

82-2-2228-8460 kimbk@yuhs.ac

Data from ClinicalTrials.gov

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