Skip to main content
OpenTrials
Completed

NCT Number: NCT01369186

Drug Drug Interactions of Aspirin and P2Y12-inhibitors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug Interaction Potentiation Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

i.v. bolus injection

Other names: Vendal

Placebo

Drug

i.v. bolus injection

Other names: Sodium chloride 0,9%

Primary outcomes

  1. Platelet function

    Time frame: 14 days

Secondary outcomes

  1. Tmax

    Time frame: 14 days

  2. Cmax

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Drug Drug Interactions of Antiplatelet Drugs and Morphine

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2011
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.