Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction (MonAMI)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Morphinhydrochloricum
Metoclopramide
Ticagrelor
Isotonic sodium chloride
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Luebeck
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Isotonic sodium chloride + Ticagrelor
Morphinhydrochloricum + Ticagrelor
Morphinhydrochloricum + Ticagrelor + Metoclopramide
Arm Description
46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Outcomes
Primary Outcome Measures
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Secondary Outcome Measures
Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test
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)
Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours
Infarct size measured by delayed enhancement magnetic resonance imaging
Microvascular obstruction measured by delayed enhancement magnetic resonance imaging
Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02627950
Brief Title
Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Acronym
MonAMI
Official Title
Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isotonic sodium chloride + Ticagrelor
Arm Type
Active Comparator
Arm Description
46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
Arm Title
Morphinhydrochloricum + Ticagrelor
Arm Type
Experimental
Arm Description
46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Arm Title
Morphinhydrochloricum + Ticagrelor + Metoclopramide
Arm Type
Experimental
Arm Description
46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Intervention Type
Drug
Intervention Name(s)
Morphinhydrochloricum
Other Intervention Name(s)
Morphin-hameln (manufacturer: hameln pharmaceuticals)
Intervention Description
5 mg morphine intravenously
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
MCP-ratiopharm (manufacturer: Ratiopharm)
Intervention Description
10 mg MCP intravenously
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique (manufacturer: AstraZeneca)
Intervention Description
180 mg ticagrelor orally
Intervention Type
Drug
Intervention Name(s)
Isotonic sodium chloride
Other Intervention Name(s)
NaCl (manufacturer: Berlin-Chemie Menarini)
Intervention Description
10 ml NaCl 0.9% intravenously
Primary Outcome Measure Information:
Title
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Time Frame
0.5, 1, 4, 6 h and 24 hours
Title
Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test
Time Frame
0.5, 1, 2, 4, 6 h and 24 hours
Title
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)
Time Frame
0.5, 1, 2, 4, 6 h and 24 hours
Title
Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours
Time Frame
0.5, 1, 2, 4, 6 h and 24 hours
Title
Infarct size measured by delayed enhancement magnetic resonance imaging
Time Frame
Day 1-4
Title
Microvascular obstruction measured by delayed enhancement magnetic resonance imaging
Description
Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass
Time Frame
Day 1-4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
University of Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33899498
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.
Results Reference
derived
PubMed Identifier
32310699
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. Erratum In: Circulation. 2020 Jul 7;142(1):e24.
Results Reference
derived
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Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
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