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

NCT03971500 | Active Not Recruiting DMC

• 1 other identifier: NFH20190529
• Study Type: interventional
• Target: 3,710
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Net adverse clinical events (NACE)

  12 months

Study Arms (4)

IVUS-guidance

EXPERIMENTAL

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; Procedure: Percutaneous coronary intervention

Angiography-guidance

ACTIVE COMPARATOR

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; Procedure: Percutaneous coronary intervention

SAPT group

EXPERIMENTAL

Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months.

Drug: AntiPlatelet therapy; Procedure: Percutaneous coronary intervention

DAPT group

ACTIVE COMPARATOR

Ticagrelor + aspirin for 12 month.

Drug: AntiPlatelet therapy; Procedure: Percutaneous coronary intervention

Interventions

AntiPlatelet therapy DRUG

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Also known as: ticagrelor, aspirin

Angiography-guidance; DAPT group; IVUS-guidance; SAPT group

Percutaneous coronary intervention PROCEDURE

PCI with DES implantation

Also known as: PCI

Angiography-guidance; DAPT group; IVUS-guidance; SAPT group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (5)

• 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.

  PMID: 30261237 BACKGROUND

• 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.

  PMID: 33621541 BACKGROUND

• Gao X, Kan J, Wu Z, Anjum M, Chen X, Chen J, Sheiban I, Mintz GS, Zhang JJ, Stone GW, Chen SL; IVUS-ACS Investigators. IVUS-Guided vs Angiography-Guided PCI in Patients With Diabetes With Acute Coronary Syndromes: The IVUS-ACS Trial. JACC Cardiovasc Interv. 2025 Feb 10;18(3):283-293. doi: 10.1016/j.jcin.2024.09.061. Epub 2024 Oct 28.

  PMID: 39466211 DERIVED

• Li X, Ge Z, Kan J, Anjum M, Xie P, Chen X, Khan HS, Guo X, Saghir T, Chen J, Gill BUA, Guo N, Sheiban I, Raza A, Wei Y, Chen F, Mintz GS, Zhang JJ, Stone GW, Chen SL; IVUS-ACS Investigators. Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial. Lancet. 2024 May 11;403(10439):1855-1865. doi: 10.1016/S0140-6736(24)00282-4. Epub 2024 Apr 8.

  PMID: 38604212 DERIVED

• Ge Z, Kan J, Gao X, Raza A, Zhang JJ, Mohydin BS, Gao F, Shao Y, Wang Y, Zeng H, Li F, Khan HS, Mengal N, Cong H, Wang M, Chen L, Wei Y, Chen F, Stone GW, Chen SL; ULTIMATE-DAPT investigators. Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial. Lancet. 2024 May 11;403(10439):1866-1878. doi: 10.1016/S0140-6736(24)00473-2. Epub 2024 Apr 7.

  PMID: 38599220 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor; Aspirin; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Shao-Liang Chen, MD, PhD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Model Details: Patients will undergo 1:1 randomization (first randomization) to either IVUS-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group based on an online Clinical Research Data Management Platform. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary TVF endpoint are scheduled at 1, 4, 6, and 12 months after the index procedure. Patients will undergo 1:1 randomization (second randomization) to either SAPT which will be the treatment group or DAPT which will be the control group based on an online Clinical Research Data Management Platform. The follow-up visits for the primary superiority bleeding endpoint and non-inferiority ischemic endpoint are scheduled at 3, 5, and 11 months after the second randomization.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: August 20, 2019
• Primary Completion: October 27, 2023
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)