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MonAMI: Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

Sponsor
University of Luebeck (Other)
Overall Status
Completed
CT.gov ID
NCT02627950
Collaborator
(none)
138
Enrollment
1
Location
3
Arms
34
Duration (Months)
4.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Isotonic sodium chloride + Ticagrelor

46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy

Drug: Ticagrelor
180 mg ticagrelor orally
Other Names:
  • Brilique (manufacturer: AstraZeneca)

    • Drug: Isotonic sodium chloride
    10 ml NaCl 0.9% intravenously
    Other Names:
  • NaCl (manufacturer: Berlin-Chemie Menarini)

    		•
    Experimental: Morphinhydrochloricum + Ticagrelor

    46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy

    Drug: Morphinhydrochloricum
    5 mg morphine intravenously
    Other Names:
  • Morphin-hameln (manufacturer: hameln pharmaceuticals)

    • Drug: Ticagrelor
    180 mg ticagrelor orally
    Other Names:
  • Brilique (manufacturer: AstraZeneca)

    		•
    Experimental: Morphinhydrochloricum + Ticagrelor + Metoclopramide

    46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy

    Drug: Morphinhydrochloricum
    5 mg morphine intravenously
    Other Names:
  • Morphin-hameln (manufacturer: hameln pharmaceuticals)

    • Drug: Metoclopramide
    10 mg MCP intravenously
    Other Names:
  • MCP-ratiopharm (manufacturer: Ratiopharm)

    • Drug: Ticagrelor
    180 mg ticagrelor orally
    Other Names:
  • Brilique (manufacturer: AstraZeneca)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test [2 hours]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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]

    5. Infarct size measured by delayed enhancement magnetic resonance imaging [Day 1-4]

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Luebeck Luebeck Germany 23538

    Sponsors and Collaborators

    • University of Luebeck

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. med. Ingo Eitel, Deputy Director, University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT02627950
    Other Study ID Numbers:
    • ESR-14-10498
    First Posted:
    Dec 11, 2015
    Last Update Posted:
    Aug 8, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Metoclopramide
    Ticagrelor

    Study Results

    No Results Posted as of Aug 8, 2019