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Completed

NCT Number: NCT02627950

Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Luebeck

Lübeck, 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ST-elevation myocardial infarction < 24 h after symptom onset or non-ST-elevation myocardial infarction with persistent chest pain < 24 h after symptom onset
  • Intended revascularization by primary percutaneous coronary intervention
  • Informed consent
  • Age ≥18 years

Exclusion criteria

  • Age <18 years
  • Active bleeding or bleeding diathesis
  • Oral anticoagulation
  • Current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-IIb-IIIa-receptor-antagonists
  • Current treatment with morphine and/or MCP <12 h
  • Contraindication for treatment with platelet inhibitors
  • Fibrinolysis <48 h
  • Percutaneous coronary intervention or coronary artery bypass grafting <3 months
  • Known glomerular filtration rate <30 ml/min
  • Severe liver dysfunction
  • Hypersensitivity to ticagrelor or any excipients
  • History of intracranial hemorrhage
  • Known pregnancy, breast-feeding or intend to become pregnant during the study period
  • Participation in other trial

Treatment and study plan

Morphinhydrochloricum

Drug

5 mg morphine intravenously

Other names: Morphin-hameln (manufacturer: hameln pharmaceuticals)

Metoclopramide

Drug

10 mg MCP intravenously

Other names: MCP-ratiopharm (manufacturer: Ratiopharm)

Ticagrelor

Drug

180 mg ticagrelor orally

Other names: Brilique (manufacturer: AstraZeneca)

isotonic sodium chloride

Drug

10 ml NaCl 0.9% intravenously

Other names: NaCl (manufacturer: Berlin-Chemie Menarini)

Primary outcomes

  1. Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test

    Time frame: 2 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Acronym: MonAMI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2015
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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