Clinical trial NCT05305482: DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial
Official title: Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
Drug-eluting stent
Dual-antiplatelet therapy
Ticagrelor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 3520
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥19 years
2. All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome
3. Provision of informed consent

Exclusion Criteria:

1. Current or potential pregnancy
2. Need of oral anticoagulation therapy
3. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Primary outcomes:
measure: Patient-Oriented Composite Endpoint (POCE)
timeFrame: At 1 year after randomization
Secondary outcomes:
measure: Device-Oriented Composite Endpoint (DOCE)
timeFrame: At 1 year after randomization
measure: All-cause death
timeFrame: At 1 year after randomization
measure: Cardiovascular death
timeFrame: At 1 year after randomization
measure: Myocardial infarction
timeFrame: At 1 year after randomization
measure: Stroke
timeFrame: At 1 year after randomization
measure: Stent thrombosis (definite or probable)
timeFrame: At 1 year after randomization
measure: Any revascularization
timeFrame: At 1 year after randomization
measure: Target-vessel revascularization
timeFrame: At 1 year after randomization
measure: Non-target vessel revascularization
timeFrame: At 1 year after randomization
measure: Target-lesion revascularization
timeFrame: At 1 year after randomization
measure: BARC type 2-5 bleeding
timeFrame: At 1 year after randomization
measure: BARC type 3-5 bleeding
timeFrame: At 1 year after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Chul-Min Ahn
role: PRINCIPAL_INVESTIGATOR
References: