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

August 6, 2019 updated by: Prof. Dr. med. Ingo Eitel, University of Luebeck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Luebeck, Germany, 23538
        • University of Luebeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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: Ticagrelor
180 mg ticagrelor orally
Other Names:
  • Brilique (manufacturer: AstraZeneca)
Drug: Morphinhydrochloricum
5 mg morphine intravenously
Other Names:
  • Morphin-hameln (manufacturer: hameln pharmaceuticals)
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: Ticagrelor
180 mg ticagrelor orally
Other Names:
  • Brilique (manufacturer: AstraZeneca)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0.5, 1, 4, 6 h and 24 hours
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
0.5, 1, 2, 4, 6 h and 24 hours
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
0.5, 1, 2, 4, 6 h and 24 hours
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
0.5, 1, 2, 4, 6 h and 24 hours
Infarct size measured by delayed enhancement magnetic resonance imaging
Time Frame: Day 1-4
Day 1-4
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
Day 1-4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (ESTIMATE)

December 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10498

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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