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

Yonsei University3,520 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,520

Conditions

Acute Coronary Syndrome

Interventions

Drug-coated stentDEVICE

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

Drug-eluting stentDEVICE

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING