Overview

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

Status:
Not yet recruiting
Trial end date:
2025-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Criteria
Inclusion Criteria:

1. Subject must be at least 19 years of age

2. Subject who is able to understand risks, benefits and treatment alternatives and sign
informed consent voluntarily.

3. Patients presenting with ACS (ST-elevation myocardial infarction [STEMI],
non-ST-elevation myocardial infarction [NSTEMI], or unstable angina)

4. Patients with at least one lesion with equal or greater than 50% diameter stenosis
requiring treatment with drug-eluting stents (DES) in native coronary artery or graft

Exclusion Criteria:

1. Patients unable to provide consent

2. Patients with known intolerance to aspirin, clopidogrel, prasugrel, or major
components of drug-eluting stents

3. Patients who have non-cardiac co-morbid conditions with life expectancy <1 year or
that may result in protocol non-compliance (per site investigator's medical judgment)

4. Patients who need chronic anti-coagulation therapy

5. Patients with active pathological bleeding

6. Pregnant or lactating women

Additional Exclusion Criteria for Antiplatelet Comparison Study:

1. Patients with history of stroke or transient ischemic attack

2. Patients 75 years of age or older

3. Patients weighing less than 60 kg