A Non-interventional Prospective Observational Study to Understand the Usage Pattern of Ticagrelor in Indian Patients With Acute Coronary Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Usage pattern of Ticagrelore in real life setting
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been provided.
- •Aged 18 years or older.
- •Male/female with ACS on Ticagrelor on discharge or ≤ 1month.
- •Patient underwent PCI, CABG or MM (Medical Management) for ACS.
- •Diagnosis of STEMI, NSTEMI or UA
排除标准
- •Patients with medical history of intracranial hemorrhage
- •All those patients who are not fit to receive Ticagrelor as per the latest prescribing information
结局指标
主要结局
Usage pattern of Ticagrelore in real life setting
时间窗: 48 Weeks
Assessing the proportion of enrolled patients with different types of ACS namely, STEMI (ST segment Elevation Myocardial Infarction), NSTEMI (Non-ST segment Elevation Myocardial Infarction) and UA (Unstable Angina)
Usage pattern of Ticagrelore
时间窗: 48 Weeks
Assessing the proportion of patients with different types of ACS management namely, PCI, CABG and Medical Management
次要结局
- Frequency of various risk factors(48 Weeks)