Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Yonsei University
- Enrollment
- 3520
- Locations
- 1
- Primary Endpoint
- Patient-Oriented Composite Endpoint (POCE)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
To test whether the polymer-free drug-coated stent (DCS) BioFreedom is noninferior to the biodegradable polymer drug-eluting stent (DES) Ultimaster in terms of 1-year patient-oriented composite endpoint (POCE, composite of all-cause mortality, any MI, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (DAPT) strategy (1-month DAPT followed ticagrelor monotherapy) after acute coronary syndrome.
Detailed Description
This trial is an open-label, randomized, multi-center study. Patients with ACS requiring percutaneous coronary intervention will be randomized with a 1:1 ratio either of DCS group or DES group. After the index procedure, DAPT (100 mg aspirin qd and 90 mg ticagrelor bid) will be given for 1 month. After this, ticagrelor monotherapy will be maintained for 11 months. Clinical events will be evaluated within 12 months after randomization.
Investigators
Chul-Min Ahn
Professor, Principal Investigator
Yonsei University
Eligibility Criteria
Inclusion Criteria
- •Age ≥19 years
- •All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome
- •Provision of informed consent
Exclusion Criteria
- •Current or potential pregnancy
- •Need of oral anticoagulation therapy
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Outcomes
Primary Outcomes
Patient-Oriented Composite Endpoint (POCE)
Time Frame: At 1 year after randomization
The composite of all-cause death, MI, or any revascularization
Secondary Outcomes
- Stent thrombosis (definite or probable)(At 1 year after randomization)
- Target-vessel revascularization(At 1 year after randomization)
- Device-Oriented Composite Endpoint (DOCE)(At 1 year after randomization)
- Myocardial infarction(At 1 year after randomization)
- All-cause death(At 1 year after randomization)
- Cardiovascular death(At 1 year after randomization)
- Non-target vessel revascularization(At 1 year after randomization)
- Target-lesion revascularization(At 1 year after randomization)
- BARC type 2-5 bleeding(At 1 year after randomization)
- Stroke(At 1 year after randomization)
- Any revascularization(At 1 year after randomization)
- BARC type 3-5 bleeding(At 1 year after randomization)