Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02408224
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2015-03-31
Brief Title:
An Observational Prospective Study to Understand the Usage Pattern of Ticagrelor With ACS Acute Coronary Syndrome
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Non-interventional Prospective Observational Study to Understand the Usage Pattern of Ticagrelor in Indian Patients With Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2018-06
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:
TREASURE
Brief Summary:
The TREASURE observational study is designed to address the need to understand the usage pattern of Ticagrelor in real life scenario in large number of ACS Acute Coronary Syndrome patients in India The aim of this national study is to understand the usage pattern including the duration of treatment of Ticagrelor in various ACS patient population undergoing PCI Percutaneous Coronary Intervention CABG Coronary Artery Bypass Graft or medical management in a real-life setting in India
Detailed Description:
This study is a multi-centre observational prospective study to be conducted at 60 hospitals across IndiaThe study will be initiated after obtaining written approval of Independent Ethics Committee IEC and written Informed consent of the patient
Patients who had been hospitalized for ACS and are on ticagrelor on discharge or on Ticagrelor therapy for 1month will be enrolled in the study and followed up for a period of 12 months During the follow-up period of up to 12 months according to the label assessment visits will follow the routine clinical practice No visits or measurements will be made mandatory by the protocol
Patients who had been hospitalized for ACS and are on ticagrelor on discharge or on Ticagrelor therapy for 1month will be enrolled in the study and followed up for a period of 12 months During the follow-up period of up to 12 months according to the label assessment visits will follow the routine clinical practice No visits or measurements will be made mandatory by the protocol
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIS-CIN-BRI-20141 | OTHER | AstraZeneca | None |