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1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials

Coronary Artery Disease Clinical Trial

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

Clinical Trial Summary

Prospective, multicenter, randomized, double-blind, placebo-controlled trials.

Clinical Trial 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 lesion's 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 >5.0 mm^2, 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 1:1 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03971500
Study type Interventional
Source Nanjing First Hospital, Nanjing Medical University
Contact
Status Active, not recruiting
Phase N/A
Start date August 20, 2019
Completion date December 30, 2025
View Details
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