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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

ConditionHigh Ischemic Risk
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorYonsei University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥50 years old

History of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago

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)

Disqualifiers

Age ≥85 years old

Pregnant women or women with potential childbearing

Life expectancy < 1 year

Inability to understand or read the informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ticagrelor-based dual-antiplatelet therapy

    Drug

    Aspirin with ticagrelor

  • Clopidogrel-based dual-antiplatelet therapy

    Drug

    Aspirin with clopidogrel

Treatment groups

3,488 Participants
are divided into 2 treatment groups
Group A: Ticagrelor-based dual-antiplatelet therapyExperimental treatment 1 intervention
Group B: Clopidogrel-based dual-antiplatelet therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

All-cause death

All-cause death at 24 months after randomization

Time frame
up to 24 months
3

Myocardial infarction

Myocardial infarction at 24 months after randomization

Time frame
up to 24 months
4

Stroke

Stroke at 24 months after randomization

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: