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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2030-02-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DCS group

Drug-coated stent group

Group Type EXPERIMENTAL

Drug-coated stent

Intervention Type DEVICE

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

DES group

Drug-eluting stent group

Group Type ACTIVE_COMPARATOR

Drug-eluting stent

Intervention Type DEVICE

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

Interventions

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Drug-coated stent

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

Intervention Type DEVICE

Drug-eluting stent

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

Intervention Type DEVICE

Other Intervention Names

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BioFreedom Ultra stent Ultimaster stent

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No