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
• 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

• Acute Kidney Injury
• Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout
• Liver Failure
• Liver Failure, Acute

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

External Links

•   SynopsisD5130N0010