Drug Drug Interactions of Antiplatelet Drugs and Morphine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Platelet function
研究概览
简要总结
Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)
详细描述
Rationale: Opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. Because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. Results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers ≥ 18 years of age
- •No intake of NSARs and P2Y12-inhibitors within 14 days before study entry
- •Written informed consent
排除标准
- •Known coagulation disorders
- •Relevant impairment of hepatic function (elevated transaminases, ≥ 2 fold)
- •Relevant impairment of renal function
- •Infectious diseases (HIV, hepatitis B and C)
- •Gestation and lactation
- •Clinically relevant abnormal laboratory values
- •Use of medication during 2 weeks before the start of the study, which may affect the validity of the study
- •General contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine
研究组 & 干预措施
Morphine
Vendal 5 mg i.v. bolus injection
干预措施: Morphine (Drug)
Placebo
Sodium chloride 0.9% i.v. bolus injection
干预措施: Placebo (Drug)
结局指标
主要结局
Platelet function
时间窗: 14 days
次要结局
- Tmax(14 days)
- Cmax(14 days)
研究者
Eva-Luise Hobl
Dr.
Medical University of Vienna