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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
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
December 3, 2015
Last Updated
August 6, 2019
Sponsor
University of Luebeck
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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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