Extended drug utilization study among patients exposed to ticagrelor, clopidogrel and prasugrel
Study identifier:D5130N00010
ClinicalTrials.gov identifier:NCT01276275
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A pharmacoepidemiological study to examine patient characteristics, drug utilization pattern and crude incidence rates of selected outcomes in new users of ticagrelor, clopidogrel and prasugrel in national Swedish registries
Medical condition
Bleeding ,arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea, gout
Phase
-
Healthy volunteers
No
Study drug
Risk of selected safety events
Sex
All
Actual Enrollment
7200
Study type
Observational
Age
N/A
Date
Study Start Date: 01 Jan 2014
Primary Completion Date: 01 Apr 2015
Study Completion Date: 01 Apr 2015
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Mar 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Exposure Group 1 First time users of ticagrelor | Drug: Risk of selected safety events First time users of ticagrelor, clopidogrel and prasugrel, respectively |
| Exposure Group 2 First time users of clopidogrel | Drug: Risk of selected safety events First time users of ticagrelor, clopidogrel and prasugrel, respectively |
| Exposure Group 3 First time users of prasugrel | Drug: Risk of selected safety events First time users of ticagrelor, clopidogrel and prasugrel, respectively |
Contacts
Investigators
Principal Investigator
Helle Kieler
Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm
