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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Stockholm, Sweden

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

Documents available

SynopsisD5130N0010
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Helle Kieler

Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm