Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor
- Registration Number
- NCT02422888
- Lead Sponsor
- Amsterdam UMC, location VUmc
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- Provision of informed consent
- Patients presenting with ST-elevation myocardial infarction <12 hours after symptom onset
- Successful percutaneous coronary intervention of the infarct-related vessel with a modern drug-eluting stent
- Intermediate stenosis in non-infarct-related vessel (50-90%)
- history of myocardial infarction
- Participation in another clinical study with an investigational product during the preceding 30 days
- history of cerebrovascular accident (CVA) or 'transient ischaemic attack' (TIA)
- History of intracranial haemorrhage
- indication or use of oral anticoagulant therapy (i.e. acenocoumarol)
- severe liver dysfunction (Child-Pugh score 10-15)
- congestive heart failure
- cardiogenic shock
- left ventricular ejection fraction < 35%
- bleeding diathesis
- age ≥ 75 or < 18
- body weight < 60 kg
- gout
- coagulation disorders
- severe pulmonary disease
- pregnancy and breast feeding
- limited life expectancy
- platelet count < 100 000/mm3
- history of drug addiction or alcohol abuse in the past 2 years
- need for chronic nonsteroidal anti-inflammatory drug
- creatinine clearance <30 mL/min or dialysis
- chronic total occlusion (CTO)
- Left main disease
- allergy or contra-indication for ticagrelor or prasugrel
- Contra-indication for adenosine
- Patients unable to be followed on-site
- Unable to undergo or contra-indications for MRI
- Contra-indication for drug-eluting stent
- Inability to obtain informed consent
- Coronary artery bypass grafting in medical history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prasugrel Prasugrel Prasugrel 10 mg once a day, tablet Duration: 1 year after PCI Ticagrelor Ticagrelor Ticagrelor 90 mg twice a day, tablet Duration: 1 year after PCI
- Primary Outcome Measures
Name Time Method Index of microcirculatory resistance (IMR) 1 month after primary PCI measured in the infarct-related artery
- Secondary Outcome Measures
Name Time Method The reactive hyperemia index (RHI) 1 month and 1 year after primary PCI Intra-myocardial haemorrhage 3 days 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
Myocardial salvage 1 month after primary PCI measured with MRI
Left ventricular ejection fraction (LVEF) recovery 1 month after primary PCI measured with MRI
Microvascular obstruction 3 days after primary PCI measured with MRI
Trial Locations
- Locations (1)
VU University Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands