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
  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 ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6000
Study Start Date: January 2014
Estimated Study Completion Date: April 2015
Estimated 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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01276275     History of Changes
Other Study ID Numbers: D5130N00010
Study First Received: January 12, 2011
Last Updated: July 17, 2014
Health Authority: European Union: European Medicines Agency

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Hemorrhage
Acute Kidney Injury
Renal Insufficiency
Liver Failure
Liver Failure, Acute
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Clopidogrel
Prasugrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014