High Ischemic RiskNCT04989257
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
A study testing Ticagrelor-based dual-antiplatelet therapy and Clopidogrel-based dual-antiplatelet therapy in people with High Ischemic Risk, run by Yonsei University at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- High Ischemic Risk
- What is being tested?
- Ticagrelor-based dual-antiplatelet therapy and Clopidogrel-based dual-antiplatelet therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,488 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
Byeong-Keuk Kim, 82-2-2228-8460, kimbk@yuhs.ac
About this study
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
- Conditions
- High Ischemic Risk
- Being tested
- Ticagrelor-based dual-antiplatelet therapy, Clopidogrel-based dual-antiplatelet therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor-based dual-antiplatelet therapyDrug
Aspirin with ticagrelor
Clopidogrel-based dual-antiplatelet therapyDrug
Aspirin with clopidogrel
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor-based dual-antiplatelet therapy | Experimental | Aspirin with ticagrelor Receives: Drug: Ticagrelor-based dual-antiplatelet therapy |
| Clopidogrel-based dual-antiplatelet therapy | Active comparator | Aspirin with clopidogrel Receives: Drug: Clopidogrel-based dual-antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death, myocardial infarction, or stroke
Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization
Measured: up to 24 months
Secondary outcomes (6)
BARC type 2, 3, or 5 bleeding
BARC type 2, 3, or 5 bleeding at 24 months after randomization
Measured: up to 24 months
All-cause death
All-cause death at 24 months after randomization
Measured: up to 24 months
Myocardial infarction
Myocardial infarction at 24 months after randomization
Measured: up to 24 months
Stroke
Stroke at 24 months after randomization
Measured: up to 24 months
Cardiac death
Cardiac death at 24 months after randomization
Measured: 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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Ischemic RiskStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy
- Masking
- None (open label)
- Enrolment
- 3,488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeong-Keuk Kim, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989257
- Sponsor's protocol ID
- 4-2021-0591
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04989257
- Acronym / sponsor ID
- 4-2021-0591
- Conditions
- High Ischemic Risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,488 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor-based dual-antiplatelet therapy | Experimental | Drug: Ticagrelor-based dual-antiplatelet therapyAspirin with ticagrelor |
| Clopidogrel-based dual-antiplatelet therapy | Active comparator | Drug: Clopidogrel-based dual-antiplatelet therapyAspirin with clopidogrel |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor-based dual-antiplatelet therapyAspirin with ticagrelor | Drug | Ticagrelor-based dual-antiplatelet therapy |
| Clopidogrel-based dual-antiplatelet therapyAspirin with clopidogrel | Drug | Clopidogrel-based dual-antiplatelet therapy |
Primary outcome
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
6 secondary outcomes
BARC type 2, 3, or 5 bleeding
Time frame: up to 24 months
All-cause death
Time frame: up to 24 months
Myocardial infarction
Time frame: up to 24 months
Stroke
Time frame: up to 24 months
Cardiac death
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byeong-Keuk Kim principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ticagrelor-based dual-antiplatelet therapy and Clopidogrel-based dual-antiplatelet therapy in people with High Ischemic Risk, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byeong-Keuk Kim (82-2-2228-8460, kimbk@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause death, myocardial infarction, or stroke (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.