Clinical trial NCT01369186: Drug Drug Interactions of Aspirin and P2Y12-inhibitors
Official title: Drug Drug Interactions of Antiplatelet Drugs and Morphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Interaction Potentiation
Myocardial Infarction
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Platelet function
timeFrame: 14 days
Secondary outcomes:
measure: Tmax
timeFrame: 14 days
measure: Cmax
timeFrame: 14 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Medical University of Vienna
name: Bernd Jilma, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hobl EL, Schmid RW, Stimpfl T, Ebner J, Jilma B. Absorption kinetics of low-dose chewable aspirin--implications for acute coronary syndromes. Eur J Clin Invest. 2015 Jan;45(1):13-7. doi: 10.1111/eci.12373.
citation: Hobl EL, Stimpfl T, Ebner J, Schoergenhofer C, Derhaschnig U, Sunder-Plassmann R, Jilma-Stohlawetz P, Mannhalter C, Posch M, Jilma B. Morphine decreases clopidogrel concentrations and effects: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2014 Feb 25;63(7):630-635. doi: 10.1016/j.jacc.2013.10.068. Epub 2013 Dec 4.
citation: Hobl EL, Reiter B, Schoergenhofer C, Schwameis M, Derhaschnig U, Lang IM, Stimpfl T, Jilma B. Morphine interaction with prasugrel: a double-blind, cross-over trial in healthy volunteers. Clin Res Cardiol. 2016 Apr;105(4):349-55. doi: 10.1007/s00392-015-0927-z. Epub 2015 Oct 22.