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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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High Ischemic Risk

Intervention / Treatment
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* Drug: Ticagrelor-based dual-antiplatelet therapy
* Drug: Clopidogrel-based dual-antiplatelet therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Age ≥85 years old Pregnant women or women with potential childbearing Life expectancy < 1 year Inability to understand or read the informed consent Need for long-term anticoagulation therapy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor-based dual-antiplatelet therapy<br>Aspirin with ticagrelor | Drug: Ticagrelor-based dual-antiplatelet therapy<br>* Aspirin with ticagrelor<br>|
| Active Comparator: Clopidogrel-based dual-antiplatelet therapy<br>Aspirin with clopidogrel | Drug: Clopidogrel-based dual-antiplatelet therapy<br>* Aspirin with clopidogrel<br>|

What is the study measuring?
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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 |