Coronary Artery Disease
Conditions
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.
Interventions
DRUGAntiPlatelet therapy
AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
PROCEDUREPercutaneous coronary intervention
PCI with DES implantation
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical events (NACE) | 12 months | The difference in NACE between IVUS- and Angiography guidance groups, or SAPT and DAPT groups. |
Countries
China
Contacts
STUDY_CHAIRShao-Liang Chen, MD, PhD
Nanjing First Hospital, Nanjing Medical University
Outcome results
None listed