Actively Recruiting
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
Led by Radboud University Medical Center · Updated on 2024-09-23
200
Participants Needed
5
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and electrocardiographical diagnosis of STEMI
- Successful PCI of the infarct-related vessel with a modern drug-eluting stent (DES) as judged by the treating physician
You will not qualify if you...
- Known allergy or contraindication for aspirin, ticagrelor, or prasugrel
- Previous PCI or myocardial infarction less than 12 months ago
- Previous cardiac surgery
- Participation in another clinical cardiology study or study about platelet aggregation/thrombosis, unless antithrombotic therapy ends due to clinical reasons
- Pregnancy or breastfeeding
- Use of oral anticoagulants
- Use of GPIIb/IIIa inhibitors during the procedure
- Planned surgery within 12 months of PCI
- Creatinine clearance below 30 mL/min or dialysis
- PCI for stent thrombosis
- Suboptimal stent result as judged by the cardiologist
- Life expectancy shorter than 13 months
- Contraindications for MRI or unable to undergo MRI (for CMR subgroup)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, Netherlands
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
3
Rijnstate
Arnhem, Netherlands
Actively Recruiting
4
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
5
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
Research Team
P
Peter Damman, MD, PhD, FESC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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