Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
NCT05986968
Summary
The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.
Eligibility
Inclusion Criteria: * Clinical and electrocardiographical diagnosis of STEMI * Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES) Exclusion Criteria: * Known allergy or contraindication for aspirin, ticagrelor or prasugrel. * Previous PCI or MI less than 12 months ago * Previous cardiac surgery * Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI)) * Pregnancy and breast feeding * Concurrent use of oral anticoagulants (OAC) * The periprocedural use of GPIIb/IIIa inhibitors * Planned surgical intervention within 12 months of PCI * Creatinine clearance \<30mL/min or dialysis * PCI of stent thrombosis * Suboptimal stent result as judged by the interventional cardiologist. * Life expectancy shorter than 13 months. * Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).
Conditions2
Interventions2
Related trials
- ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography — Jung-min Ahn
- Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention — Peking Union Medical College Hospital
- COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes — Montreal Heart Institute
- Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization — Takeshi Morimoto
- IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome — Shanghai Zhongshan Hospital
- Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation — Insel Gruppe AG, University Hospital Bern
- Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation — Kyoto University
- Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer — Centre Hospitalier Universitaire de Besancon
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT05986968