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Drug Drug Interactions of Aspirin and P2Y12-inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Eva-Luise Hobl, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01369186
First received: June 7, 2011
Last updated: May 21, 2013
Last verified: May 2013

June 7, 2011
May 21, 2013
May 2011
May 2014   (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.

Not Provided
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
    Intervention: Drug: Morphine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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):630-5. doi: 10.1016/j.jacc.2013.10.068. Epub 2013 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
May 2014
May 2014   (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
Yes
Contact: Bernd Jilma, Prof. Dr. 43 1 40400 ext 2981 bernd.jilma@meduniwien.ac.at
Contact: Eva-Luise Hobl, Dr. 43 1 40400 ext 2981 eva-luise.hobl@meduniwien.ac.at
Austria
 
NCT01369186
2010-023761-22
No
Eva-Luise Hobl, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
May 2013

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