Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
NCT ID: NCT02627950
Last Updated: 2019-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
138 participants
INTERVENTIONAL
2015-12-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Isotonic sodium chloride + Ticagrelor
46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
Ticagrelor
180 mg ticagrelor orally
Isotonic sodium chloride
10 ml NaCl 0.9% intravenously
Morphinhydrochloricum + Ticagrelor
46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Morphinhydrochloricum
5 mg morphine intravenously
Ticagrelor
180 mg ticagrelor orally
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
Morphinhydrochloricum
5 mg morphine intravenously
Metoclopramide
10 mg MCP intravenously
Ticagrelor
180 mg ticagrelor orally
Interventions
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Morphinhydrochloricum
5 mg morphine intravenously
Metoclopramide
10 mg MCP intravenously
Ticagrelor
180 mg ticagrelor orally
Isotonic sodium chloride
10 ml NaCl 0.9% intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Intended revascularization by primary percutaneous coronary intervention
3. Informed consent
4. Age ≥18 years
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Luebeck
OTHER
Responsible Party
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Prof. Dr. med. Ingo Eitel
Deputy Director
Locations
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University of Luebeck
Lübeck, , Germany
Countries
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References
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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.
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.
Other Identifiers
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ESR-14-10498
Identifier Type: -
Identifier Source: org_study_id
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