Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Isotonic sodium chloride + Ticagrelor
46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
干预措施: Ticagrelor (Drug)
Isotonic sodium chloride + Ticagrelor
46 patients with NaCl i.v. and 180 mg ticagrelor orally pre revascularization plus medical standard therapy
干预措施: Isotonic sodium chloride (Drug)
Morphinhydrochloricum + Ticagrelor
46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
干预措施: Morphinhydrochloricum (Drug)
Morphinhydrochloricum + Ticagrelor
46 patients with 5 mg morphine i.v. and 180 mg ticagrelor pre revascularization plus medical standard therapy
干预措施: Ticagrelor (Drug)
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
干预措施: Morphinhydrochloricum (Drug)
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
干预措施: Metoclopramide (Drug)
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
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Platelet activity 2 hours after administration of loading dose of ticagrelor measured by VerifyNow-P2Y12-test
时间窗: 2 hours
次要结局
- 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)
- Microvascular obstruction measured by delayed enhancement magnetic resonance imaging(Day 1-4)
研究者
Prof. Dr. med. Ingo Eitel
Deputy Director
University Hospital Schleswig-Holstein