Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03971500
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2019-05-30
Brief Title:
1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS IVUS-ACS and ULTIMATE-DAPT Trials
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Comparison of 1-month Versus 12-month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents Guided by Either Intravascular Ultrasound or Angiography in Patients With Acute Coronary Syndrome The Prospective Multicenter Randomized Placebo-controlled IVUS-ACS and ULTIMATE-DAPT Trials
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Prospective multicenter randomized double-blind placebo-controlled trials
Detailed Description:
A total of 3486 subjects with ACS who met inclusion criteria and do not have any exclusion criterion will be randomized to IVUS- or Angiography-guidance group first randomization In the IVUS-guidance group IVUS will be used to evaluate the lesions specificity and to measure lesion length landing zone and reference vessel diameter prior-to stenting and to assess stent expansion extension apposition and possible complications after stent implantation The IVUS- defined criteria for the optimal stent deployment included 1 the minimal stent area MSA in the stented segment is 50 mm2 or 90 of the MLA at the distal reference segments 2 plaque burden 5-mm proximal or distal to the stent edge is 55 and 3 absence of Type B edge dissection Further treatment will be required if stenting procedure is defined as suboptimal according to IVUS definition IVUS will be not allowed to be used in the Angiography-guidance group
Those patients who have had no death STEMI stroke ST TVR or major bleeding BARC 3 or 5 within 30 days and have continued on aspirin and ticagrelor for 30 days without interruption for 48 hours will be randomized 11 to
1 Ticagrelor plus matching placebo for an additional 11 months SAPT group
2 Ticagrelor plus aspirin study drug for an additional 11 months DAPT group Follow-up of all subjects will continue for 1 year with an option for additional follow-up to 3 years
Those patients who have had no death STEMI stroke ST TVR or major bleeding BARC 3 or 5 within 30 days and have continued on aspirin and ticagrelor for 30 days without interruption for 48 hours will be randomized 11 to
1 Ticagrelor plus matching placebo for an additional 11 months SAPT group
2 Ticagrelor plus aspirin study drug for an additional 11 months DAPT group Follow-up of all subjects will continue for 1 year with an option for additional follow-up to 3 years
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?:
True
Is an FDA AA801 Violation?:
None