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

University of Luebeck

Status and phase: Completed; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Drug: Metoclopramide; Drug: Isotonic sodium chloride; Drug: Morphinhydrochloricum; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02627950

ESR-14-10498

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

138 participants in 3 patient groups

Isotonic sodium chloride + Ticagrelor

Active Comparator group

Description:

46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy

Treatment:

Drug: Ticagrelor

Drug: Isotonic sodium chloride

Morphinhydrochloricum + Ticagrelor

Experimental group

Description:

46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy

Treatment:

Drug: Ticagrelor

Drug: Morphinhydrochloricum

Morphinhydrochloricum + Ticagrelor + Metoclopramide

Experimental group

Description:

46 patients with 5 mg morphine i.v. and 10 mg MCP i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy

Treatment:

Drug: Ticagrelor

Drug: Morphinhydrochloricum

Drug: Metoclopramide