Drug Drug Interactions of Aspirin and P2Y12-inhibitors

Medical University of Vienna95 enrolled

Overview

Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Drug Interaction Potentiation Myocardial Infarction

Interventions

MorphineDRUG

i.v. bolus injection

PlaceboDRUG

i.v. bolus injection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

Platelet function

Time frame: 14 days

Secondary Outcomes

Tmax

Time frame: 14 days

Cmax

Time frame: 14 days

Data from ClinicalTrials.gov

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