RecruitingNot ApplicableNCT05986968

Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage


Sponsor

Radboud University Medical Center

Enrollment

200 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Aspirin and a drug called Ticagrelor for people with st elevation myocardial infarction. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTicagrelor

Ticagrelor monotherapy for 12 months

DRUGAspirin

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months


Locations(5)

Noordwest Ziekenhuisgroep Alkmaar

Alkmaar, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Rijnstate

Arnhem, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Radboudumc

Nijmegen, Netherlands

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NCT05986968


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