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

  • Korea, Republic of
      • 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:

  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

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
Drug: Ticagrelor-based dual-antiplatelet therapy
Aspirin with ticagrelor
Active Comparator: Clopidogrel-based dual-antiplatelet therapy
Aspirin with clopidogrel
Drug: Clopidogrel-based dual-antiplatelet therapy
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

Yonsei University

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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