Acute Myocardial Infarction
Conditions
Brief summary
The current prospective, randomized, controlled MonAMI trial aims to systematically examine the effects of morphine on the platelet inhibitory effects of the orally administered platelet inhibitor ticagrelor in patients with acute myocardial infarction. In addition, the potential positive or negative effects of MCP in combination with morphine on platelet inhibition will be studied.
Interventions
DRUGMorphinhydrochloricum
5 mg morphine intravenously
DRUGMetoclopramide
10 mg MCP intravenously
DRUGTicagrelor
180 mg ticagrelor orally
10 ml NaCl 0.9% intravenously
Sponsors
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ST-elevation myocardial infarction \< 24 h after symptom onset or non-ST-elevation myocardial infarction with persistent chest pain \< 24 h after symptom onset 2. Intended revascularization by primary percutaneous coronary intervention 3. Informed consent 4. Age ≥18 years
Exclusion criteria
1. Age \<18 years 2. Active bleeding or bleeding diathesis 3. Oral anticoagulation 4. Current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-IIb-IIIa-receptor-antagonists 5. Current treatment with morphine and/or MCP \<12 h 6. Contraindication for treatment with platelet inhibitors 7. Fibrinolysis \<48 h 8. Percutaneous coronary intervention or coronary artery bypass grafting \<3 months 9. Known glomerular filtration rate \<30 ml/min 10. Severe liver dysfunction 11. Hypersensitivity to ticagrelor or any excipients 12. History of intracranial hemorrhage 13. Known pregnancy, breast-feeding or intend to become pregnant during the study period 14. Participation in other trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test | 2 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test | 0.5, 1, 2, 4, 6 h and 24 hours | — |
| Percentage of patients with high on-treatment platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor (measured by VerifyNow-P2Y12-test) | 0.5, 1, 2, 4, 6 h and 24 hours | — |
| Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test | 0.5, 1, 4, 6 h and 24 hours | — |
| Infarct size measured by delayed enhancement magnetic resonance imaging | Day 1-4 | — |
| Microvascular obstruction measured by delayed enhancement magnetic resonance imaging | Day 1-4 | Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass |
| Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours | 0.5, 1, 2, 4, 6 h and 24 hours | — |
Countries
Germany
Outcome results
None listed