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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02627950
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ingo Eitel, University of Schleswig-Holstein

Tracking Information
First Submitted Date  ICMJE December 3, 2015
First Posted Date  ICMJE December 11, 2015
Last Update Posted Date August 8, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2015)
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Infarct size measured by delayed enhancement magnetic resonance imaging [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Official Title  ICMJE Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Drug: Morphinhydrochloricum
    5 mg morphine intravenously
    Other Name: Morphin-hameln (manufacturer: hameln pharmaceuticals)
  • Drug: Metoclopramide
    10 mg MCP intravenously
    Other Name: MCP-ratiopharm (manufacturer: Ratiopharm)
  • Drug: Ticagrelor
    180 mg ticagrelor orally
    Other Name: Brilique (manufacturer: AstraZeneca)
  • Drug: Isotonic sodium chloride
    10 ml NaCl 0.9% intravenously
    Other Name: NaCl (manufacturer: Berlin-Chemie Menarini)
Study Arms  ICMJE
  • Active Comparator: Isotonic sodium chloride + Ticagrelor
    46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
    Interventions:
    • Drug: Ticagrelor
    • Drug: Isotonic sodium chloride
  • Experimental: Morphinhydrochloricum + Ticagrelor
    46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
    Interventions:
    • Drug: Morphinhydrochloricum
    • Drug: Ticagrelor
  • 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
    Interventions:
    • Drug: Morphinhydrochloricum
    • Drug: Metoclopramide
    • Drug: Ticagrelor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2015)
138
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02627950
Other Study ID Numbers  ICMJE ESR-14-10498
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. Ingo Eitel, University of Schleswig-Holstein
Study Sponsor  ICMJE University of Luebeck
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Luebeck
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP