Status:
RECRUITING
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
Lead Sponsor:
Radboud University Medical Center
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05986968
Start Date
July 6 2023
End Date
December 1 2025
Last Update
September 23 2024
Active Locations (5)
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1
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, Netherlands
2
Amsterdam UMC
Amsterdam, Netherlands
3
Rijnstate
Arnhem, Netherlands
4
Medisch Spectrum Twente
Enschede, Netherlands