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

Last updated: September 20, 2024
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Heart Disease

Cardiac Ischemia

Treatment

Ticagrelor

Aspirin

Clinical Study ID

NCT05986968
NL82646.091.22
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Clinical and electrocardiographical diagnosis of STEMI

  • Successful PCI (according to the treating physician) of the infarct-related vesselwith a modern drug-eluting stent (DES)

Exclusion

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 plateletaggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this otherstudy 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 CMRsubgroup population).

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Ticagrelor
Phase:
Study Start date:
July 06, 2023
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Noordwest Ziekenhuisgroep Alkmaar

    Alkmaar,
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Rijnstate

    Arnhem,
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • Medisch Centrum Leeuwarden

    Leeuwarden,
    Netherlands

    Site Not Available

  • Radboudumc

    Nijmegen,
    Netherlands

    Active - Recruiting

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