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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

The main goal of this clinical trial is to assess the safety of direct omission of aspirin after Percutaneous Coronary Intervention (PCI) in patients with ST elevation myocardial infarction (STEMI). The secondary objectives are to demonstrate the reduction of intramyocardial haemorrhage and infarct size, which will be measured after 1 week; to compare clinical bleeding outcomes and to compare platelet reactivity and inflammatory response in STEMI patients receiving ticagrelor monotherapy versus dual antiplatelet therapy.

Patients will be treated with either ticagrelor monotherapy or dual antiplatelet therapy (aspirin plus ticagrelor) after PCI. They will be compared to see if the omission of aspirin is safe in terms of major adverse cardiac and cerebral events at 13 months follow-up.

Eligibility

Inclusion Criteria:

  • Clinical and electrocardiographical diagnosis of STEMI
  • Successful PCI (according to the treating physician) of the infarct-related vessel with a modern 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.
  • 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.
  • Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).

Study details
    ST Elevation Myocardial Infarction

NCT05986968

Radboud University Medical Center

27 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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