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

NCT ID: NCT01276275

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposure Group 1

First time users of ticagrelor

Risk of selected safety events

Intervention Type DRUG

First time users of ticagrelor, clopidogrel and prasugrel, respectively

Exposure Group 2

First time users of clopidogrel

Risk of selected safety events

Intervention Type DRUG

First time users of ticagrelor, clopidogrel and prasugrel, respectively

Exposure Group 3

First time users of prasugrel

Risk of selected safety events

Intervention Type DRUG

First time users of ticagrelor, clopidogrel and prasugrel, respectively

Interventions

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Risk of selected safety events

First time users of ticagrelor, clopidogrel and prasugrel, respectively

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helle Kieler, MD, PhD, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Related Links

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Other Identifiers

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D5130N00010

Identifier Type: -

Identifier Source: org_study_id

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