Clinical trial NCT02627950: Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Official title: Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 138
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
timeFrame: 2 hours
Secondary outcomes:
measure: Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test
timeFrame: 0.5, 1, 4, 6 h and 24 hours
measure: Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test
timeFrame: 0.5, 1, 2, 4, 6 h and 24 hours
measure: 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)
timeFrame: 0.5, 1, 2, 4, 6 h and 24 hours
measure: Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours
timeFrame: 0.5, 1, 2, 4, 6 h and 24 hours
measure: Infarct size measured by delayed enhancement magnetic resonance imaging
timeFrame: Day 1-4
measure: Microvascular obstruction measured by delayed enhancement magnetic resonance imaging
timeFrame: Day 1-4
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University of Luebeck
Study officials:
References:
citation: Stiermaier T, Schaefer P, Meyer-Saraei R, Saad M, de Waha-Thiele S, Poss J, Fuernau G, Graf T, Kurz T, Frydrychowicz A, Barkhausen J, Desch S, Thiele H, Eitel I. Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Myocardial and Microvascular Injury in Acute Myocardial Infarction: Insights From the Randomized MonAMI Trial. J Am Heart Assoc. 2021 May 4;10(9):e018881. doi: 10.1161/JAHA.120.018881. Epub 2021 Apr 26.
citation: Saad M, Meyer-Saraei R, de Waha-Thiele S, Stiermaier T, Graf T, Fuernau G, Langer HF, Kurz T, Poss J, Barkhausen J, Desch S, Eitel I, Thiele H. Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Ticagrelor-Induced Platelet Inhibition in Acute Myocardial Infarction: The Randomized MonAMI Trial. Circulation. 2020 Apr 21;141(16):1354-1356. doi: 10.1161/CIRCULATIONAHA.119.042816. Epub 2020 Apr 20. No abstract available.