Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

Phase 4

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Morphinhydrochloricum; Drug: Ticagrelor; Drug: Isotonic sodium chloride; Drug: Metoclopramide

• Registration Number: NCT02627950
• Lead Sponsor: University of Luebeck

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 available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-11
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphinhydrochloricum + Ticagrelor	Morphinhydrochloricum	46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Morphinhydrochloricum + Ticagrelor	Ticagrelor	46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Morphinhydrochloricum + Ticagrelor + Metoclopramide	Morphinhydrochloricum	46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
Isotonic sodium chloride + Ticagrelor	Isotonic sodium chloride	46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
Isotonic sodium chloride + Ticagrelor	Ticagrelor	46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
Morphinhydrochloricum + Ticagrelor + Metoclopramide	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
Morphinhydrochloricum + Ticagrelor + Metoclopramide	Ticagrelor	46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy

Primary Outcome Measures

Name	Time	Method
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test	2 hours

Secondary Outcome Measures

Name	Time	Method
Microvascular obstruction measured by delayed enhancement magnetic resonance imaging	Day 1-4	Cardiac magnetic resonance imaging equivalent of angiographic no-reflow, expressed as percentage of left ventricular mass
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
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
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
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
Infarct size measured by delayed enhancement magnetic resonance imaging	Day 1-4

Trial Locations

Locations (1)

University of Luebeck; 🇩🇪 Luebeck, Germany