Extended Drug Utilization Study Among Patients Exposed to Ticagrelor, Clopidogrel and Prasugrel
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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 |
|---|
|
Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout |
| 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 The Health Improvement Network (THIN) Database in the United Kingdom (UK). |
- 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 ]
- 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: | March 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Exposure Group 1 |
| Exposure Group 2 |
| Exposure Group 3 |
Eligibility| Ages Eligible for Study: | 20 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients aged 20 to 84 years with at least two years of enrollment with the general practitioner and one year since first health contact recorded in the THIN database before their first study drug prescription. The study period will start the first month after ticagrelor market introduction in the UK. Review of study outcomes including chart reviews is estimated to start in March 2012
Inclusion Criteria:
- at least two years of enrollment with the general practitioner and one year since first health contact recorded in the THIN database before their first study drug prescription
Exclusion Criteria:
- No exclusion criteria
Contacts and Locations 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: | February 4, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by AstraZeneca:
|
Acute coronary syndrome, thienopyridine, epidemiology |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Dyspnea Heart Failure Hemorrhage Acute Kidney Injury Renal Insufficiency Liver Failure Liver Failure, Acute Heart Diseases Cardiovascular Diseases Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
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 |
ClinicalTrials.gov processed this record on June 17, 2013