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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

Primary Purpose

High Ischemic Risk

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor-based dual-antiplatelet therapy
Clopidogrel-based dual-antiplatelet therapy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Ischemic Risk

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital, Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor-based dual-antiplatelet therapy

Clopidogrel-based dual-antiplatelet therapy

Arm Description

Aspirin with ticagrelor

Aspirin with clopidogrel

Outcomes

Primary Outcome Measures

Composite of all-cause death, myocardial infarction, or stroke
Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization

Secondary Outcome Measures

BARC type 2, 3, or 5 bleeding
BARC type 2, 3, or 5 bleeding at 24 months after randomization
All-cause death
All-cause death at 24 months after randomization
Myocardial infarction
Myocardial infarction at 24 months after randomization
Stroke
Stroke at 24 months after randomization
Cardiac death
Cardiac death at 24 months after randomization
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

Full Information

First Posted
July 1, 2021
Last Updated
August 3, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04989257
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Ischemic Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3488 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor-based dual-antiplatelet therapy
Arm Type
Experimental
Arm Description
Aspirin with ticagrelor
Arm Title
Clopidogrel-based dual-antiplatelet therapy
Arm Type
Active Comparator
Arm Description
Aspirin with clopidogrel
Intervention Type
Drug
Intervention Name(s)
Ticagrelor-based dual-antiplatelet therapy
Intervention Description
Aspirin with ticagrelor
Intervention Type
Drug
Intervention Name(s)
Clopidogrel-based dual-antiplatelet therapy
Intervention Description
Aspirin with clopidogrel
Primary Outcome Measure Information:
Title
Composite of all-cause death, myocardial infarction, or stroke
Description
Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
BARC type 2, 3, or 5 bleeding
Description
BARC type 2, 3, or 5 bleeding at 24 months after randomization
Time Frame
up to 24 months
Title
All-cause death
Description
All-cause death at 24 months after randomization
Time Frame
up to 24 months
Title
Myocardial infarction
Description
Myocardial infarction at 24 months after randomization
Time Frame
up to 24 months
Title
Stroke
Description
Stroke at 24 months after randomization
Time Frame
up to 24 months
Title
Cardiac death
Description
Cardiac death at 24 months after randomization
Time Frame
up to 24 months
Title
Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding
Description
Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding at 24 months after randomization
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byeong-Keuk Kim
Phone
82-2-2228-8460
Email
kimbk@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim
Phone
82-2-2228-8460
Email
kimbk@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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