- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04989257
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
August 3, 2021 updated by: Yonsei University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3488
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Byeong-Keuk Kim
- Phone Number: 82-2-2228-8460
- Email: kimbk@yuhs.ac
Study Locations
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ticagrelor-based dual-antiplatelet therapy
Aspirin with ticagrelor
|
Aspirin with ticagrelor
|
Active Comparator: Clopidogrel-based dual-antiplatelet therapy
Aspirin with clopidogrel
|
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
Time Frame: up to 24 months
|
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
Time Frame: up to 24 months
|
BARC type 2, 3, or 5 bleeding at 24 months after randomization
|
up to 24 months
|
All-cause death
Time Frame: up to 24 months
|
All-cause death at 24 months after randomization
|
up to 24 months
|
Myocardial infarction
Time Frame: up to 24 months
|
Myocardial infarction at 24 months after randomization
|
up to 24 months
|
Stroke
Time Frame: up to 24 months
|
Stroke at 24 months after randomization
|
up to 24 months
|
Cardiac death
Time Frame: up to 24 months
|
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
Time Frame: up to 24 months
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Byeong-Keuk Kim, Yonsei University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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