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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03971500
• Other study ID #: NFH20190529
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3710
• Est. completion date: December 30, 2025
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Enrollment into the study will require meeting at least one of these clinical syndromes within 1 month.

• Unstable angina, defined as rest pain for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis =90% or a ruptured plaque or thrombotic lesion

• Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome.

• ST elevation MI (STEMI)

Exclusion Criteria:

• Unable or unwilling to provide informed consent

• Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula

• Previous coronary artery bypass graft (CABG)

• Any planned surgery within 90 days

• Any reason why any antiplatelet therapy might need to be discontinued within 12 months

• Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m^2

• Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants)

• Platelet count < 100,000 mm^3

• Contraindication to aspirin

• Contraindication to ticagrelor

• Liver cirrhosis

• Women of child-bearing potential

• Life expectancy < 1 year

• Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Procedure:
• Percutaneous coronary intervention
PCI with DES implantation

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Ge Z, Gao XF, Kan J, Kong XQ, Zuo GF, Ye F, Tian NL, Lin S, Liu ZZ, Shao YB, He YQ, Wen SY, Yang Q, Xia Y, Wang ZZ, Xiao PX, Li F, Zeng HS, Yang S, Wang Y, Tao L, Gao DS, Qu H, Qian XS, Han YL, Chen F, Zhang JJ, Chen SL. Comparison of one-month versus twelve-month dual antiplatelet therapy after implantation of drug-eluting stents guided by either intravascular ultrasound or angiography in patients with acute coronary syndrome: rationale and design of prospective, multicenter, randomized, controlled IVUS-ACS and ULTIMATE-DAPT trial. Am Heart J. 2021 Jun;236:49-58. doi: 10.1016/j.ahj.2021.02.014. Epub 2021 Feb 20. — View Citation

Zhang J, Gao X, Kan J, Ge Z, Han L, Lu S, Tian N, Lin S, Lu Q, Wu X, Li Q, Liu Z, Chen Y, Qian X, Wang J, Chai D, Chen C, Li X, Gogas BD, Pan T, Shan S, Ye F, Chen SL. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3126-3137. doi: 10.1016/j.jacc.2018.09.013. Epub 2018 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF)	The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.	12 months
Primary	Clinically-relevant bleeding	The difference in clinically-relevant bleeding (BARC =2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.	11 months
Primary	Major adverse cardiovascular and cerebrovascular events (MACCE)	The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.	11 months
Secondary	Net adverse clinical events (NACE)	The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups.	12 months