Phase 2 pilot study evaluates ticagrelor monotherapy safety after stenting for acute MI

Status: COMPLETED | Phase: PHASE2 Condition(s): Acute Myocardial Infarction Intervention(s): Ticagrelor 90mg (DRUG) A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction. The study is a single-centre, single-arm, prospective phase II study 200 patients who undergo coronary artery stenting due to NSTEMI or STEMI will be included. Primary endpoint (variable): The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months. Detailed: A pilot study with 200 subjects undergoing coronary stenting due to NSTEMI or STEMI. All patients will undergo invasive coronary angiography and clinically indicated Percutaneous Coronary Intervention (PCI). PCI will be performed using EES and OCT guidance using the MLDMAX algorithm (Morphology, Length, Diameter, Medial dissection, Apposition, Xpansion). Eligibility criteria will be assessed after completion of PCI. Patients will be given a drug diary to document and as a reminder of the twice daily ticagrelor administration. The Data Safety Monitoring Board (DSMB) will continuously review the outcomes for these patients. After the first 50 patients have been recruited and at least 30 of these patients have reached 3-month follow-up or had the primary outcome, the DSMB will convene to d Primary Outcome(s): Major adverse cardiac event Enrollment: 200 (ACTUAL) Lead Sponsor: Vastra Gotaland Region Start: 2021-12-14 | Primary Completion: 2025-06-26