Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
MonAMI
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedAugust 8, 2019
August 1, 2019
2.8 years
December 3, 2015
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
2 hours
Secondary Outcomes (6)
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
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
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
Infarct size measured by delayed enhancement magnetic resonance imaging
Day 1-4
- +1 more secondary outcomes
Study Arms (3)
Isotonic sodium chloride + Ticagrelor
ACTIVE COMPARATOR46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
Morphinhydrochloricum + Ticagrelor
EXPERIMENTAL46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Morphinhydrochloricum + Ticagrelor + Metoclopramide
EXPERIMENTAL46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Interventions
5 mg morphine intravenously
10 mg MCP intravenously
180 mg ticagrelor orally
10 ml NaCl 0.9% intravenously
Eligibility Criteria
You may qualify if:
- ST-elevation myocardial infarction \< 24 h after symptom onset or non-ST-elevation myocardial infarction with persistent chest pain \< 24 h after symptom onset
- Intended revascularization by primary percutaneous coronary intervention
- Informed consent
- Age ≥18 years
You may not qualify if:
- Age \<18 years
- Active bleeding or bleeding diathesis
- Oral anticoagulation
- Current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-IIb-IIIa-receptor-antagonists
- Current treatment with morphine and/or MCP \<12 h
- Contraindication for treatment with platelet inhibitors
- Fibrinolysis \<48 h
- Percutaneous coronary intervention or coronary artery bypass grafting \<3 months
- Known glomerular filtration rate \<30 ml/min
- Severe liver dysfunction
- Hypersensitivity to ticagrelor or any excipients
- History of intracranial hemorrhage
- Known pregnancy, breast-feeding or intend to become pregnant during the study period
- Participation in other trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Luebeck
Lübeck, 23538, Germany
Related Publications (2)
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.
PMID: 33899498DERIVEDSaad 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.
PMID: 32310699DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
December 3, 2015
First Posted
December 11, 2015
Study Start
December 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
August 8, 2019
Record last verified: 2019-08