Drug Interaction Potentiation, Myocardial Infarction
Conditions
Brief summary
Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)
Detailed description
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.
Interventions
DRUGMorphine
i.v. bolus injection
DRUGPlacebo
i.v. bolus injection
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers ≥ 18 years of age * No intake of NSARs and P2Y12-inhibitors within 14 days before study entry * Written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet function | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Tmax | 14 days |
| Cmax | 14 days |
Countries
Austria
Outcome results
None listed