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CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 4

NCT05066789 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-18

No results posted yet for this study

Summary

This study is multi-center, open label, two-by-two factorial, randomized, noninferiority trial to compare the efficacy and safety of polymer-free cobalt-chromium thin drug-coated stents (BioFreedom Ultra) with biodegradable polymer ultrathin sirolimus-eluting stents (Orsiro Mission) and prasugrel monotherapy after 1-month dual antiplatelet therapy (DAPT) of aspirin plus prasugrel with 12-month DAPT of aspirin plus prasugrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Conditions

Interventions

DEVICE

Type of stent

1:1 randomization to biodegradable polymer DES (Orsiro Mission) and polymer-free DCS (Biofreedom)

DRUG

Duration of DAPT

1:1 randomization to 1-month DAPT thereafter prasugrel monotherapy and 12-month DAPT (aspirin + prasugrel)

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Joo-Yong Hahn, MD, PhD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2024-03-22
Completion
2024-03-22

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066789 on ClinicalTrials.gov