1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: AntiPlatelet therapyProcedure: Percutaneous coronary intervention
- Registration Number
- NCT03971500
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3710
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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVUS-guidance AntiPlatelet therapy 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. IVUS-guidance Percutaneous coronary intervention 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. Angiography-guidance AntiPlatelet therapy 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. Angiography-guidance Percutaneous coronary intervention 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. SAPT group AntiPlatelet therapy Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months. SAPT group Percutaneous coronary intervention Ticagrelor + aspirin for 1 month followed by ticagrelor plus matching placebo for an additional 11 months. DAPT group AntiPlatelet therapy Ticagrelor + aspirin for 12 month. DAPT group Percutaneous coronary intervention Ticagrelor + aspirin for 12 month.
- Primary Outcome Measures
Name Time Method Target vessel failure (TVF) 12 months The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.
Clinically-relevant bleeding 11 months The difference in clinically-relevant bleeding (BARC ≥2) will be calculated from 1 month to 12 months between SAPT and DAPT groups.
Major adverse cardiovascular and cerebrovascular events (MACCE) 11 months The difference in MACCE will be calculated from 1 month to 12 months between SAPT and DAPT groups.
- Secondary Outcome Measures
Name Time Method Net adverse clinical events (NACE) 12 months The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups.
Trial Locations
- Locations (1)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China