Drug Drug Interactions of Aspirin and P2Y12-inhibitors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eva-Luise Hobl, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01369186
First received: June 7, 2011
Last updated: April 7, 2015
Last verified: April 2015

June 7, 2011
April 7, 2015
May 2011
January 2015   (final data collection date for primary outcome measure)
Platelet function [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01369186 on ClinicalTrials.gov Archive Site
  • Tmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Drug Drug Interactions of Aspirin and P2Y12-inhibitors
Drug Drug Interactions of Antiplatelet Drugs and Morphine
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • VA Drug Interactions [VA Drug Interaction]
  • Myocardial Infarction
  • Drug: Morphine
    i.v. bolus injection
    Other Name: Vendal
  • Drug: Placebo
    i.v. bolus injection
    Other Name: Sodium chloride 0,9%
  • Active Comparator: Morphine
    Vendal 5 mg i.v. bolus injection
    Intervention: Drug: Morphine
  • Placebo Comparator: Placebo
    Sodium chloride 0.9% i.v. bolus injection
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01369186
2010-023761-22
No
Not Provided
Not Provided
Eva-Luise Hobl, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Bernd Jilma, Prof. Dr. Medical University of Vienna
Medical University of Vienna
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP