Clincosm LogoSign in Get a demo

Drug Drug Interactions of Aspirin and P2Y12-inhibitors

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01369186
Collaborator
(none)
95
Enrollment
1
Location
2
Arms
44.1
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Drug Drug Interactions of Antiplatelet Drugs and Morphine
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Morphine

Vendal 5 mg i.v. bolus injection

Drug: Morphine
i.v. bolus injection
Other Names:
  • Vendal

    		•
    Placebo Comparator: Placebo

    Sodium chloride 0.9% i.v. bolus injection

    Drug: Placebo
    i.v. bolus injection
    Other Names:
  • Sodium chloride 0,9%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Platelet function [14 days]

    Secondary Outcome Measures

    1. Tmax [14 days]

    2. Cmax [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna, Department of Clinical Pharmacology Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Bernd Jilma, Prof. Dr., Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eva-Luise Hobl, Dr., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT01369186
    Other Study ID Numbers:
    • 2010-023761-22
    First Posted:
    Jun 8, 2011
    Last Update Posted:
    Mar 27, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Morphine

    Study Results

    No Results Posted as of Mar 27, 2017