DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug-coated stent, Drug-eluting stent.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial
Overview
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.
Interventions
- Device Drug-coated stent
The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group. - Device Drug-eluting stent
The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.
Primary outcome measures
- Patient-Oriented Composite Endpoint (POCE) [Time frame: At 1 year after randomization]
Secondary outcome measures (12)
- Device-Oriented Composite Endpoint (DOCE) [Time frame: At 1 year after randomization]
- All-cause death [Time frame: At 1 year after randomization]
- Cardiovascular death [Time frame: At 1 year after randomization]
- Myocardial infarction [Time frame: At 1 year after randomization]
- Stroke [Time frame: At 1 year after randomization]
- Stent thrombosis (definite or probable) [Time frame: At 1 year after randomization]
- Any revascularization [Time frame: At 1 year after randomization]
- Target-vessel revascularization [Time frame: At 1 year after randomization]
- Non-target vessel revascularization [Time frame: At 1 year after randomization]
- Target-lesion revascularization [Time frame: At 1 year after randomization]
- BARC type 2-5 bleeding [Time frame: At 1 year after randomization]
- BARC type 3-5 bleeding [Time frame: At 1 year after randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei Cardiovascular Hospital, Yonsei University College of Medicine — Seoul
Identifiers
NCT: NCT05305482 · 1-2021-0089