Drug Drug Interactions of Aspirin and P2Y12-inhibitors
Primary Purpose
Drug Interaction Potentiation, Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Morphine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Drug Interaction Potentiation
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna, Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Morphine
Placebo
Arm Description
Vendal 5 mg i.v. bolus injection
Sodium chloride 0.9% i.v. bolus injection
Outcomes
Primary Outcome Measures
Platelet function
Secondary Outcome Measures
Tmax
Cmax
Full Information
NCT ID
NCT01369186
First Posted
June 7, 2011
Last Updated
March 23, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01369186
Brief Title
Drug Drug Interactions of Aspirin and P2Y12-inhibitors
Official Title
Drug Drug Interactions of Antiplatelet Drugs and Morphine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Interaction Potentiation, Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Vendal 5 mg i.v. bolus injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% i.v. bolus injection
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Vendal
Intervention Description
i.v. bolus injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium chloride 0,9%
Intervention Description
i.v. bolus injection
Primary Outcome Measure Information:
Title
Platelet function
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Tmax
Time Frame
14 days
Title
Cmax
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Jilma, Prof. Dr.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
25402445
Citation
Hobl EL, Schmid RW, Stimpfl T, Ebner J, Jilma B. Absorption kinetics of low-dose chewable aspirin--implications for acute coronary syndromes. Eur J Clin Invest. 2015 Jan;45(1):13-7. doi: 10.1111/eci.12373.
Results Reference
background
PubMed Identifier
24315907
Citation
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):630-635. doi: 10.1016/j.jacc.2013.10.068. Epub 2013 Dec 4. Erratum In: J Am Coll Cardiol. 2018 Aug 7;72(6):705.
Results Reference
background
PubMed Identifier
26493304
Citation
Hobl EL, Reiter B, Schoergenhofer C, Schwameis M, Derhaschnig U, Lang IM, Stimpfl T, Jilma B. Morphine interaction with prasugrel: a double-blind, cross-over trial in healthy volunteers. Clin Res Cardiol. 2016 Apr;105(4):349-55. doi: 10.1007/s00392-015-0927-z. Epub 2015 Oct 22.
Results Reference
derived
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Drug Drug Interactions of Aspirin and P2Y12-inhibitors
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