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

April 7, 2026 updated by: Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Actual)

3710

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVUS-guidance
In the IVUS-guided DES implantation group, optimal stent deployment criteria included: 1) the MLA 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 any of those 3 criteria was not met.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Names:
  • ticagrelor, aspirin
Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Names:
  • PCI
Active Comparator: Angiography-guidance
In the Angiography-guided DES implantation group, stent diameter and length will be selected by visual estimation with a stent/artery ratio of 1.1:1.0. Post-dilation with a noncompliant balloon (balloon/stent diameter=1.0:1.0) inflated at >18 atm will be performed for all lesions. Angiographic success is defined as Thrombolysis In Myocardial Infarction (TIMI) grade 3, residual stenosis <20%, and the absence of >Type B dissection.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Names:
  • ticagrelor, aspirin
Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Names:
  • PCI
Experimental: SAPT group
Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Names:
  • ticagrelor, aspirin
Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Names:
  • PCI
Active Comparator: DAPT group
Ticagrelor + aspirin for 12 month.
Drug: AntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
Other Names:
  • ticagrelor, aspirin
Procedure: Percutaneous coronary intervention
PCI with DES implantation
Other Names:
  • PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel failure (TVF)
Time Frame: 12 months
The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.
12 months
Clinically-relevant bleeding
Time Frame: 11 months
The difference in clinically-relevant bleeding (BARC ≥2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.
11 months
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: 11 months
The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.
11 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net adverse clinical events (NACE)
Time Frame: 12 months
The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Shao-Liang Chen, MD, PhD, Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Actual)

October 27, 2023

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFH20190529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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