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

Nanjing Medical University

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Drug: AntiPlatelet therapy; Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03971500

NFH20190529

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,710 patients

Sex: All

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,710 participants in 4 patient groups

IVUS-guidance

Experimental group

Description:

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.

Treatment:

Procedure: Percutaneous coronary intervention

Drug: AntiPlatelet therapy

Angiography-guidance

Active Comparator group

Description:

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.

Treatment:

Procedure: Percutaneous coronary intervention

Drug: AntiPlatelet therapy

SAPT group

Experimental group

Description:

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

Treatment:

Procedure: Percutaneous coronary intervention

Drug: AntiPlatelet therapy

DAPT group

Active Comparator group

Description:

Ticagrelor + aspirin for 12 month.

Treatment:

Procedure: Percutaneous coronary intervention

Drug: AntiPlatelet therapy