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Drug Drug Interactions of Aspirin and P2Y12-inhibitors

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ClinicalTrials.gov Identifier: NCT01369186
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Eva-Luise Hobl, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE June 7, 2011
First Posted Date  ICMJE June 8, 2011
Last Update Posted Date March 27, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
Platelet function [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
  • Tmax [ Time Frame: 14 days ]
  • Cmax [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Drug Interactions of Aspirin and P2Y12-inhibitors
Official Title  ICMJE Drug Drug Interactions of Antiplatelet Drugs and Morphine
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Drug Interaction Potentiation
  • Myocardial Infarction
Intervention  ICMJE
  • Drug: Morphine
    i.v. bolus injection
    Other Name: Vendal
  • Drug: Placebo
    i.v. bolus injection
    Other Name: Sodium chloride 0,9%
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2015)
95
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2011)
35
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01369186
Other Study ID Numbers  ICMJE 2010-023761-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eva-Luise Hobl, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernd Jilma, Prof. Dr. Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date March 2017

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