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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04989257
Enrollment
3488
Registered
2021-08-04
Start date
2021-08-31
Completion date
2026-06-30
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Ischemic Risk

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

Interventions

DRUGTicagrelor-based dual-antiplatelet therapy

Aspirin with ticagrelor

DRUGClopidogrel-based dual-antiplatelet therapy

Aspirin with clopidogrel

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite of all-cause death, myocardial infarction, or strokeup to 24 monthsComposite of all-cause death, myocardial infarction, or stroke at 24 months after randomization

Secondary

MeasureTime frameDescription
All-cause deathup to 24 monthsAll-cause death at 24 months after randomization
Myocardial infarctionup to 24 monthsMyocardial infarction at 24 months after randomization
BARC type 2, 3, or 5 bleedingup to 24 monthsBARC type 2, 3, or 5 bleeding at 24 months after randomization
Cardiac deathup to 24 monthsCardiac death at 24 months after randomization
Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleedingup to 24 monthsComposite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding at 24 months after randomization
Strokeup to 24 monthsStroke at 24 months after randomization

Countries

South Korea

Contacts

Primary ContactByeong-Keuk Kim
kimbk@yuhs.ac82-2-2228-8460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026