DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Drug-coated stent; Device: Drug-eluting stent

• Registration Number: NCT05305482
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-08-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Primary Completion: 2030-02-14
• Study Completion: 2030-02-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3520

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCS group	Drug-coated stent	Drug-coated stent group
DES group	Drug-eluting stent	Drug-eluting stent group

Primary Outcome Measures

Name	Time	Method
Patient-Oriented Composite Endpoint (POCE)	At 1 year after randomization	The composite of all-cause death, MI, or any revascularization

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis (definite or probable)	At 1 year after randomization	By the Academic Research Consortium-2 Consensus Document
Target-vessel revascularization	At 1 year after randomization	Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion
Device-Oriented Composite Endpoint (DOCE)	At 1 year after randomization	The composite of cardiovascular death, MI (not clearly attributable to a non-target vessel), or clinically-driven target-lesion revascularization (TLR)
Myocardial infarction	At 1 year after randomization	A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document
All-cause death	At 1 year after randomization	All death including cardiovascular death
Cardiovascular death	At 1 year after randomization	Death resulting from cardiovascular causes or undetermined cause of death not attributable to any other category because of the absence of any relevant source documents
Non-target vessel revascularization	At 1 year after randomization	Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel
Target-lesion revascularization	At 1 year after randomization	Clinically indicated or ischemia driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
BARC type 2-5 bleeding	At 1 year after randomization	According to a consensus report from the Bleeding Academic Research Consortium
Stroke	At 1 year after randomization	Loss of neurologic function caused by an ischemic or hemorrhagic event
Any revascularization	At 1 year after randomization	All revascularizations including target-vessel revascularization and and non-target-vessel revascularization
BARC type 3-5 bleeding	At 1 year after randomization	According to a consensus report from the Bleeding Academic Research Consortium

Trial Locations

Locations (1)

Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of