Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study

EudraCT number: 2021-000823-11

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.

2021-12-04

2025-09-01

2025-12-01

Recruiting

Early phase I

200

Inclusion Criteria: 1. Men or women at least 18 years old. 2. Pre- or intra-procedure treatment with ticagrelor. 3. Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis \<50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3. 4. PCI guided by optical coherence tomography (OCT) with MLDMAX workflow 5. Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed) 6. Subject has signed and dated the informed consent form. Exclusion Criteria: 1. Planned PCI or any planned surgical intervention within the next 6 months. 2. Any indication for chronic anticoagulant therapy 3. Positive COVID-19 antigen or PCR test regardless of symptoms 4. History of definite stent thrombosis 5. Left main coronary artery stenting. 6. Stent thrombosis/restenosis as a culprit lesion. 7. Visible thrombus on angiography after PCI 8. Usage of glycoprotein IIb/IIIa inhibitors 9. Any bifurcation lesion with stenting of both branches. 10. Any treated lesion within an arterial or venous graft. 11. Any additional lesion(s) that need(s) a staged revascularization. 12. Known ejection fraction \<30%. 13. Known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2). 14. Any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months. 15. Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator). 16. Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir) 17. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception. 18. Expected inability (by the investigator) to comply with the protocol 19. Subjects incapable to giving consent personally

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-centre, single-arm, prospective phase II study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-05-16