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

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · May 30, 2019

Keywords

ClinConnect Summary

The IVUS-ACS and ULTIMATE-DAPT trials are studying how long patients with acute coronary syndrome (ACS) should continue taking dual antiplatelet therapy (DAPT) after undergoing a procedure called percutaneous coronary intervention (PCI). DAPT typically involves taking two medications to help prevent blood clots. This trial compares two different durations of DAPT: one month versus twelve months, to see which is more effective and safe for patients. The study is currently active but not recruiting new participants.

To be eligible for this trial, participants must have experienced certain heart-related events, like unstable angina or heart attacks (both ST elevation MI and non-ST elevation MI), within the past month. However, some individuals may not qualify, such as those with severe kidney issues or a history of certain medical conditions that could interfere with the study. Participants will be closely monitored throughout the trial, and they can expect regular check-ups to assess their health and how they are responding to the treatment. This research is important for understanding the best approaches to care for patients with coronary artery disease following PCI.

Gender

ALL

Eligibility 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.)