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

Yonsei University

Status: Enrolling

Conditions: Acute Coronary Syndrome

Treatments: Device: Drug-eluting stent; Device: Drug-coated stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05305482

1-2021-0089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,520 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,520 participants in 2 patient groups

DCS group

Experimental group

Description:

Drug-coated stent group

Treatment:

Device: Drug-coated stent

DES group

Active Comparator group

Description:

Drug-eluting stent group

Treatment:

Device: Drug-eluting stent