Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

NCT ID: NCT02627950

Last Updated: 2019-08-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

180 mg ticagrelor orally

Isotonic sodium chloride

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Morphinhydrochloricum

Intervention Type DRUG

5 mg morphine intravenously

Ticagrelor

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Morphinhydrochloricum

Intervention Type DRUG

5 mg morphine intravenously

Metoclopramide

Intervention Type DRUG

10 mg MCP intravenously

Ticagrelor

Intervention Type DRUG

180 mg ticagrelor orally

Interventions

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Morphinhydrochloricum

5 mg morphine intravenously

Intervention Type DRUG

Metoclopramide

10 mg MCP intravenously

Intervention Type DRUG

Ticagrelor

180 mg ticagrelor orally

Intervention Type DRUG

Isotonic sodium chloride

10 ml NaCl 0.9% intravenously

Intervention Type DRUG

Other Intervention Names

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Morphin-hameln (manufacturer: hameln pharmaceuticals) MCP-ratiopharm (manufacturer: Ratiopharm) Brilique (manufacturer: AstraZeneca) NaCl (manufacturer: Berlin-Chemie Menarini)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Ingo Eitel

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Luebeck

Lübeck, , Germany

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 33899498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32310699 (View on PubMed)

Other Identifiers

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ESR-14-10498

Identifier Type: -

Identifier Source: org_study_id

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