Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04568083
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2020-09-15
Brief Title:
Patient Characteristics Persistence to Treatment and Outcome Events in Patients Treated With Ticagrelor 60 mg After Myocardial Infarction in Real-world Clinical Practice
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
An Observational Register-based Study on Ticagrelor 60 mg Persistence and Event Rates in Clinical Practice in the US and Europe
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALETHEIA
Brief Summary:
This is an observational study based on secondary data extracted from multiple register-based data sources in the US and Europe Sweden United Kingdom Italy Germany The study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction in real-world clinical practice and describe their patient characteristics and duration of treatment If the a priori threshold of 5000 person-years on treatment with ticagrelor 60 mg is met outcome events bleeding and cardiovascular events will also be analysed and described
Detailed Description:
This observational cohort study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction MI and describe their patient characteristics and persistence to treatment To contextualise the characteristics of the ticagrelor patients two reference cohorts will be created including patients treated with another P2Y12 inhibitor than ticagrelor clopidogrel prasugrel or ticlopidine and patients not treated with any P2Y12 inhibitor within a comparable timepoint from an MI as for the ticagrelor 60 mg patients If the a priori threshold of 5000 person-years on treatment with ticagrelor 60 mg is met to ensure sufficient precision outcome events bleeding and cardiovascular events will also be analysed and described Outcome events will only be described in the ticagrelor cohorts no comparison of outcomes will be made between the ticagrelor and the reference cohorts
The primary outcome is bleeding requiring hospitalisation The secondary outcomes include components of the primary outcome and cardiovascular outcomes Persistence to treatment with ticagrelor 60 mg will also be assessed The study will be performed in the US and 4 European countries Sweden United Kingdom Italy Germany
The primary outcome is bleeding requiring hospitalisation The secondary outcomes include components of the primary outcome and cardiovascular outcomes Persistence to treatment with ticagrelor 60 mg will also be assessed The study will be performed in the US and 4 European countries Sweden United Kingdom Italy Germany
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None