Clinical trial NCT05986968: Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
Official title: Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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).

Primary outcomes:
measure: Composite of major adverse cardiac and cerebral events (MACCE)
timeFrame: 1, 3 and 13 months after primary PCI
measure: Intramyocardial haemorrhage (IMH)
timeFrame: day 5-8 post primary PCI
Secondary outcomes:
measure: Bleeding complications
timeFrame: 1, 3 and 13 months after primary PCI
measure: All-cause mortality
timeFrame: 1, 3 and 13 months after primary PCI
measure: Platelet reactivity
timeFrame: 5-8 days
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep Alkmaar
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References: