Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05305482
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2022-03-22
Brief Title:
DCS Versus DES for One-month DAPT in Patients With ACS ONE-PASS Trial
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome ONE-PASS Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONE-PASS
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
Detailed Description:
This trial is an open-label randomized multi-center study Patients with ACS requiring percutaneous coronary intervention will be randomized with a 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None