Clinical trial NCT03971500: 1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 3710
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 12 months
measure: Clinically-relevant bleeding
timeFrame: 11 months
measure: Major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 11 months
Secondary outcomes:
measure: Net adverse clinical events (NACE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD, PhD
role: STUDY_CHAIR
References:
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.
citation: 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.