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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05305482

Collaborator

(none)

3,520

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Device: Drug-coated stent Device: Drug-eluting stent	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3520 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DCS group Drug-coated stent group	Device: Drug-coated stent The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group. Other Names: BioFreedom Ultra stent
Active Comparator: DES group Drug-eluting stent group	Device: Drug-eluting stent The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group. Other Names: Ultimaster stent

Arm

Intervention/Treatment

Experimental: DCS group

Drug-coated stent group

Device: Drug-coated stent

The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.

Other Names:

BioFreedom Ultra stent

Active Comparator: DES group

Drug-eluting stent group

Device: Drug-eluting stent

The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.

Other Names:

Ultimaster stent

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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
Stroke [At 1 year after randomization]
Loss of neurologic function caused by an ischemic or hemorrhagic event
Stent thrombosis (definite or probable) [At 1 year after randomization]
By the Academic Research Consortium-2 Consensus Document
Any revascularization [At 1 year after randomization]
All revascularizations including target-vessel revascularization and and non-target-vessel revascularization
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
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
BARC type 3-5 bleeding [At 1 year after randomization]
According to a consensus report from the Bleeding Academic Research Consortium

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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