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

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University
• Treatments: Aspirin; Ticagrelor

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.)