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

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ClinicalTrials.gov Identifier: NCT02627950
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ingo Eitel, University of Schleswig-Holstein

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
Acute Myocardial Infarction Drug: Morphinhydrochloricum Drug: Metoclopramide Drug: Ticagrelor Drug: Isotonic sodium chloride Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : December 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 Name: Brilique (manufacturer: AstraZeneca)

Drug: Isotonic sodium chloride
10 ml NaCl 0.9% intravenously
Other Name: 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 Name: Morphin-hameln (manufacturer: hameln pharmaceuticals)

Drug: Ticagrelor
180 mg ticagrelor orally
Other Name: 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 Name: Morphin-hameln (manufacturer: hameln pharmaceuticals)

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

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




Primary Outcome Measures :
  1. Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 0.5, 1, 2, 4, 6 h and 24 hours ]
  5. Infarct size measured by delayed enhancement magnetic resonance imaging [ Time Frame: Day 1-4 ]
  6. Microvascular obstruction measured by delayed enhancement magnetic resonance imaging [ Time Frame: Day 1-4 ]
    Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627950


Locations
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Germany
University of Luebeck
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck

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Responsible Party: Prof. Dr. med. Ingo Eitel, Deputy Director, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02627950    
Other Study ID Numbers: ESR-14-10498
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Morphine
Metoclopramide
Ticagrelor
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists