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

Acute Coronary Syndrome Clinical Trial

— ONE-PASS  

Official title:

Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305482
• Other study ID #: 1-2021-0089
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Yonsei University
• Contact: Chul-Min Ahn
• Phone: +82-2-2228-8532
• Email: drcello[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3520
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Device:
• Drug-coated stent
The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.
• Drug-eluting stent
The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Oriented Composite Endpoint (POCE)	The composite of all-cause death, MI, or any revascularization	At 1 year after randomization
Secondary	Device-Oriented Composite Endpoint (DOCE)	The composite of cardiovascular death, MI (not clearly attributable to a non-target vessel), or clinically-driven target-lesion revascularization (TLR)	At 1 year after randomization
Secondary	All-cause death	All death including cardiovascular death	At 1 year after randomization
Secondary	Cardiovascular death	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	At 1 year after randomization
Secondary	Myocardial infarction	A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document	At 1 year after randomization
Secondary	Stroke	Loss of neurologic function caused by an ischemic or hemorrhagic event	At 1 year after randomization
Secondary	Stent thrombosis (definite or probable)	By the Academic Research Consortium-2 Consensus Document	At 1 year after randomization
Secondary	Any revascularization	All revascularizations including target-vessel revascularization and and non-target-vessel revascularization	At 1 year after randomization
Secondary	Target-vessel revascularization	Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion	At 1 year after randomization
Secondary	Non-target vessel revascularization	Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel	At 1 year after randomization
Secondary	Target-lesion revascularization	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	At 1 year after randomization
Secondary	BARC type 2-5 bleeding	According to a consensus report from the Bleeding Academic Research Consortium	At 1 year after randomization
Secondary	BARC type 3-5 bleeding	According to a consensus report from the Bleeding Academic Research Consortium	At 1 year after randomization