Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— MonAMI  

Official title:

Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627950
• Other study ID #: ESR-14-10498
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: October 2018

Study information

• Verified date: August 2019
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Morphinhydrochloricum
5 mg morphine intravenously
• Metoclopramide
10 mg MCP intravenously
• Ticagrelor
180 mg ticagrelor orally
• Isotonic sodium chloride
10 ml NaCl 0.9% intravenously

Locations

Country	Name	City	State
Germany	University of Luebeck	Luebeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test		2 hours
Secondary	Platelet reactivity 0.5, 1, 4, 6 and 24 hours after loading dose of ticagrelor measured by VerifyNow-P2Y12-test		0.5, 1, 4, 6 h and 24 hours
Secondary	Platelet reactivity 0.5, 1, 2, 4, 6 and 24 hours after loading dose of ticagrelor measured by Vasodilator Stimulated Phosphoprotein-test		0.5, 1, 2, 4, 6 h and 24 hours
Secondary	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)		0.5, 1, 2, 4, 6 h and 24 hours
Secondary	Ticagrelor plasma levels and levels of active serum metabolites after 0.5, 1, 2, 4, 6 and 24 hours		0.5, 1, 2, 4, 6 h and 24 hours
Secondary	Infarct size measured by delayed enhancement magnetic resonance imaging		Day 1-4
Secondary	Microvascular obstruction measured by delayed enhancement magnetic resonance imaging	Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass	Day 1-4