Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-03-26 @ 4:05 AM
Study NCT ID:
NCT02627950
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test', 'timeFrame': '0.5, 1, 4, 6 h and 24 hours'}, {'measure': 'Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test', 'timeFrame': '0.5, 1, 2, 4, 6 h and 24 hours'}, {'measure': '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)', 'timeFrame': '0.5, 1, 2, 4, 6 h and 24 hours'}, {'measure': 'Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours', 'timeFrame': '0.5, 1, 2, 4, 6 h and 24 hours'}, {'measure': 'Infarct size measured by delayed enhancement magnetic resonance imaging', 'timeFrame': 'Day 1-4'}, {'measure': 'Microvascular obstruction measured by delayed enhancement magnetic resonance imaging', 'timeFrame': 'Day 1-4', 'description': 'Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '33899498', 'type': 'DERIVED', '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.'}, {'pmid': '32310699', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ST-elevation myocardial infarction \\< 24 h after symptom onset or non-ST-elevation myocardial infarction with persistent chest pain \\< 24 h after symptom onset\n2. Intended revascularization by primary percutaneous coronary intervention\n3. Informed consent\n4. Age ≥18 years\n\nExclusion Criteria:\n\n1. Age \\<18 years\n2. Active bleeding or bleeding diathesis\n3. Oral anticoagulation\n4. Current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-IIb-IIIa-receptor-antagonists\n5. Current treatment with morphine and/or MCP \\<12 h\n6. Contraindication for treatment with platelet inhibitors\n7. Fibrinolysis \\<48 h\n8. Percutaneous coronary intervention or coronary artery bypass grafting \\<3 months\n9. Known glomerular filtration rate \\<30 ml/min\n10. Severe liver dysfunction\n11. Hypersensitivity to ticagrelor or any excipients\n12. History of intracranial hemorrhage\n13. Known pregnancy, breast-feeding or intend to become pregnant during the study period\n14. Participation in other trial'}, 'identificationModule': {'nctId': 'NCT02627950', 'acronym': 'MonAMI', 'briefTitle': 'Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'ESR-14-10498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isotonic sodium chloride + Ticagrelor', 'description': '46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy', 'interventionNames': ['Drug: Ticagrelor', 'Drug: Isotonic sodium chloride']}, {'type': 'EXPERIMENTAL', 'label': 'Morphinhydrochloricum + Ticagrelor', 'description': '46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy', 'interventionNames': ['Drug: Morphinhydrochloricum', 'Drug: Ticagrelor']}, {'type': 'EXPERIMENTAL', 'label': 'Morphinhydrochloricum + Ticagrelor + Metoclopramide', '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', 'interventionNames': ['Drug: Morphinhydrochloricum', 'Drug: Metoclopramide', 'Drug: Ticagrelor']}], 'interventions': [{'name': 'Morphinhydrochloricum', 'type': 'DRUG', 'otherNames': ['Morphin-hameln (manufacturer: hameln pharmaceuticals)'], 'description': '5 mg morphine intravenously', 'armGroupLabels': ['Morphinhydrochloricum + Ticagrelor', 'Morphinhydrochloricum + Ticagrelor + Metoclopramide']}, {'name': 'Metoclopramide', 'type': 'DRUG', 'otherNames': ['MCP-ratiopharm (manufacturer: Ratiopharm)'], 'description': '10 mg MCP intravenously', 'armGroupLabels': ['Morphinhydrochloricum + Ticagrelor + Metoclopramide']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brilique (manufacturer: AstraZeneca)'], 'description': '180 mg ticagrelor orally', 'armGroupLabels': ['Isotonic sodium chloride + Ticagrelor', 'Morphinhydrochloricum + Ticagrelor', 'Morphinhydrochloricum + Ticagrelor + Metoclopramide']}, {'name': 'Isotonic sodium chloride', 'type': 'DRUG', 'otherNames': ['NaCl (manufacturer: Berlin-Chemie Menarini)'], 'description': '10 ml NaCl 0.9% intravenously', 'armGroupLabels': ['Isotonic sodium chloride + Ticagrelor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University of Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director', 'investigatorFullName': 'Prof. Dr. med. Ingo Eitel', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}