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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01369186 |
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Date of registration:
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07/06/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Drug Drug Interactions of Aspirin and P2Y12-inhibitors
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Scientific title:
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Drug Drug Interactions of Antiplatelet Drugs and Morphine |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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95 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01369186 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Austria
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Contacts
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Name:
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Bernd Jilma, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Drug Interaction Potentiation
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Intervention(s)
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Drug: Morphine
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Drug: Placebo
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Primary Outcome(s)
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Platelet function
[Time Frame: 14 days]
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Secondary Outcome(s)
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Cmax
[Time Frame: 14 days]
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Tmax
[Time Frame: 14 days]
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Secondary ID(s)
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2010-023761-22
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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