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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01276275
First Posted: January 13, 2011
Last Update Posted: March 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose

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.


Condition Intervention
Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout Drug: Risk of selected safety events

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Drug utilization: Description of patient characteristics and drug usage [ Time Frame: Up to one year after entry into study cohort ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 7200
Study Start Date: January 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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),
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276275


Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Helle Kieler, MD, PhD, Assoc Prof Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01276275     History of Changes
Other Study ID Numbers: D5130N00010
First Submitted: January 12, 2011
First Posted: January 13, 2011
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by AstraZeneca:
Acute coronary syndrome, thienopyridine, epidemiology

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Dyspnea
Liver Failure
Acute Kidney Injury
Liver Failure, Acute
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Clopidogrel
Prasugrel Hydrochloride
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs