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NCT01276275 Clinical Trial

Extended Drug Utilization Study Among Patients Exposed to Ticagrelor, Clopidogrel and Prasugrel

Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01276275
Other study ID # D5130N00010
Secondary ID
Status Completed
Phase N/A
First received January 12, 2011
Last updated March 30, 2016
Start date January 2014
Est. completion date April 2015

Study information
Verified date March 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Observational

Clinical Trial Summary

The purpose of the study is to describe patient characteristics and drug usage among patients that are prescribed ticagrelor for the first time and to compare them with patients who are prescribed clopidogrel and prasugrel for the first time.

A further purpose is to ascertain and estimate the crude incidence rate of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout among new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.

Recruitment information / eligibility
Status Completed
Enrollment 7200
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- First time users of ticagrelor, clopidogrel and prasugrel, respectively

Exclusion Criteria:

- Individuals with more than one of above three antiplatelet drugs dispensed the same day

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Risk of selected safety events
First time users of ticagrelor, clopidogrel and prasugrel, respectively

Locations
Country Name City State
Sweden Research Site Stockholm

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Drug utilization: Description of patient characteristics and drug usage Up to one year after entry into study cohort No
Secondary Follow-up of safety outcomes: First occurrence of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout Up to one year after entry into study cohort. Yes

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