NCT05305482

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,520 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Drug-coated stent	The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.
DEVICE	Drug-eluting stent	The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.

Timeline

• Start date: 2022-08-10
• Primary completion: 2030-02-14
• Completion: 2030-02-14
• First posted: 2022-03-31
• Last updated: 2025-05-21

Locations

1 site across 1 country: South Korea