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

NCT04989257 | Not Yet Recruiting DMC

• 1 other identifier: 4-2021-0591
• Study Type: interventional
• Target: 3,488
• Locations: 1 country
• Sites: 1

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

Conditions

High Ischemic Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• BARC type 2, 3, or 5 bleeding

  up to 24 months

• All-cause death

  up to 24 months

• Myocardial infarction

  up to 24 months

• Stroke

  up to 24 months

• Cardiac death

  up to 24 months

Study Arms (2)

Ticagrelor-based dual-antiplatelet therapy

EXPERIMENTAL

Aspirin with ticagrelor

Drug: Ticagrelor-based dual-antiplatelet therapy

Clopidogrel-based dual-antiplatelet therapy

ACTIVE COMPARATOR

Aspirin with clopidogrel

Drug: Clopidogrel-based dual-antiplatelet therapy

Interventions

Ticagrelor-based dual-antiplatelet therapy DRUG

Aspirin with ticagrelor

Ticagrelor-based dual-antiplatelet therapy

Clopidogrel-based dual-antiplatelet therapy DRUG

Aspirin with clopidogrel

Clopidogrel-based dual-antiplatelet therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Study Officials

• Byeong-Keuk Kim

  Yonsei University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byeong-Keuk Kim

CONTACT

82-2-2228-8460; kimbk@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 4, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)