Myocardial Infarction
Conditions
Keywords
ST elevation myocardial infarction, Percutaneous coronary intervention, Endothelial function, Ticagrelor, Prasugrel
Brief summary
The current trial will compare the protective effect of ticagrelor and prasugrel on microvascular dysfunction in patients with revascularized ST elevation myocardial infarction.
Detailed description
Coronary microvascular dysfunction is highly prevalent in revascularized ST-elevation myocardial infarction and has important prognostic implications. Current data suggest that ticagrelor might be superior to prasugrel in the reduction of coronary microvasculature dysfunction. Thus, we have designed a clinical trial that will compare microvascular function in revascularized ST-elevation myocardial infarction patients at treatment steady state with ticagrelor or prasugrel. Coronary microvascular dysfunction will be assessed with the index of microcirculatory resistance after primary percutaneous coronary intervention and at 1 month follow-up in the infarct-related vessel and non-infarct related vessel.
Interventions
DRUGTicagrelor
After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a maintenance dose of ticagrelor 90 mg twice a day for 1 year.
DRUGPrasugrel
After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a single loading dose of prasugrel 60 mg (1 day after standard loading dose ticagrelor),followed by a maintenance dose of prasugrel 10 mg once a day for 1 year.
Sponsors
Erasmus Medical Center
Hospital San Carlos, Madrid
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Nijmegen
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent 2. Patients presenting with ST-elevation myocardial infarction \<12 hours after symptom onset 3. Successful percutaneous coronary intervention of the infarct-related vessel with a modern drug-eluting stent 4. Intermediate stenosis in non-infarct-related vessel (50-90%)
Exclusion criteria
1. history of myocardial infarction 2. Participation in another clinical study with an investigational product during the preceding 30 days 3. history of cerebrovascular accident (CVA) or 'transient ischaemic attack' (TIA) 4. History of intracranial haemorrhage 5. indication or use of oral anticoagulant therapy (i.e. acenocoumarol) 6. severe liver dysfunction (Child-Pugh score 10-15) 7. congestive heart failure 8. cardiogenic shock 9. left ventricular ejection fraction \< 35% 10. bleeding diathesis 11. age ≥ 75 or \< 18 12. body weight \< 60 kg 13. gout 14. coagulation disorders 15. severe pulmonary disease 16. pregnancy and breast feeding 17. limited life expectancy 18. platelet count \< 100 000/mm3 19. history of drug addiction or alcohol abuse in the past 2 years 20. need for chronic nonsteroidal anti-inflammatory drug 21. creatinine clearance \<30 mL/min or dialysis 22. chronic total occlusion (CTO) 23. Left main disease 24. allergy or contra-indication for ticagrelor or prasugrel 25. Contra-indication for adenosine 26. Patients unable to be followed on-site 27. Unable to undergo or contra-indications for MRI 28. Contra-indication for drug-eluting stent 29. Inability to obtain informed consent 30. Coronary artery bypass grafting in medical history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Index of microcirculatory resistance (IMR) | 1 month after primary PCI | measured in the infarct-related artery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The reactive hyperemia index (RHI) | 1 month and 1 year after primary PCI | — |
| Myocardial salvage | 1 month after primary PCI | measured with MRI |
| Left ventricular ejection fraction (LVEF) recovery | 1 month after primary PCI | measured with MRI |
| Delta Index of microcirculatory resistance (IMR) | Baseline vs. 1 month follow-up | measured in the infarct-related artery and non-infarct related artery |
| Asymmetric Dimethylarginine (ADMA) levels | 1 month after primary PCI | Blood measurements |
| Intra-myocardial haemorrhage | 3 days after primary PCI | measured with MRI |
| Microvascular obstruction | 3 days after primary PCI | measured with MRI |
Countries
Netherlands
Outcome results
None listed