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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01276275
First received: January 12, 2011
Last updated: July 17, 2014
Last verified: July 2014

January 12, 2011
July 17, 2014
January 2014
April 2015   (final data collection date for primary outcome measure)
Drug utilization: Description of patient characteristics and drug usage [ Time Frame: Up to one year after entry into study cohort ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276275 on ClinicalTrials.gov Archive Site
Follow-up of safety outcomes: First occurrence of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout [ Time Frame: Up to one year after entry into study cohort. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Extended Drug Utilization Study Among Patients Exposed to Ticagrelor, Clopidogrel and Prasugrel
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

All patients aged 20 to 84 years before their first study drug dispension (start date) will be included in the study. The study period will start the first month after ticagrelor market introduction in Sweden (the first of June 2011),

Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout
Drug: Risk of selected safety events
First time users of ticagrelor, clopidogrel and prasugrel, respectively
  • Exposure Group 1
    First time users of ticagrelor
    Intervention: Drug: Risk of selected safety events
  • Exposure Group 2
    First time users of clopidogrel
    Intervention: Drug: Risk of selected safety events
  • Exposure Group 3
    First time users of prasugrel
    Intervention: Drug: Risk of selected safety events
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6000
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01276275
D5130N00010
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Helle Kieler, MD, PhD, Assoc Prof Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP