Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02430493
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2015-04-27
Brief Title:
Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multi-Centre Prospective Cohort Non-Interventional Study About Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients
Status:
COMPLETED
Status Verified Date:
2018-03
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:
YingLong
Brief Summary:
The primary objective is to describe the safety and tolerability of ticagrelor by assessment of adverse events characteristics reporting rate severity relationship and risk factors especially the bleeding events as defined in 81 and other serious adverse events SAEs during 1-year follow up in Chinese acute coronary syndrome ACS patients
Detailed Description:
The trial is a multi-centre prospective cohort non-interventional study to be conducted in the department of cardiology from approximately 20 tier-2 or 3 hospitals China The study requires Chinese subjects aged over 18 diagnosed as ACS and treated with ticagrelor at least one tablet from the department of cardiology in the around 20 tier-2 or 3 hospitals The subjects will be tracked up to 1 month after the discontinuation of ticagrelor for AE events and 1 year after enrollment for major cardiovascular events This is an observational study The prescribing doctor is in charge of prescribing or discontinuation ticagrelor The investigator in an observational study may not intervene in the treatment All 1000 subjects related data will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None