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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3710 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2025-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

AntiPlatelet therapy

Intervention Type DRUG

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Percutaneous coronary intervention

Intervention Type PROCEDURE

PCI with DES implantation

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.

Group Type ACTIVE_COMPARATOR

AntiPlatelet therapy

Intervention Type DRUG

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Percutaneous coronary intervention

Intervention Type PROCEDURE

PCI with DES implantation

SAPT group

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

Group Type EXPERIMENTAL

AntiPlatelet therapy

Intervention Type DRUG

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Percutaneous coronary intervention

Intervention Type PROCEDURE

PCI with DES implantation

DAPT group

Ticagrelor + aspirin for 12 month.

Group Type ACTIVE_COMPARATOR

AntiPlatelet therapy

Intervention Type DRUG

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Percutaneous coronary intervention

Intervention Type PROCEDURE

PCI with DES implantation

Interventions

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AntiPlatelet therapy

AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.

Intervention Type DRUG

Percutaneous coronary intervention

PCI with DES implantation

Intervention Type PROCEDURE

Other Intervention Names

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ticagrelor, aspirin PCI

Eligibility Criteria

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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.)

Eligible Sex

ALL

Accepts Healthy Volunteers

No