An Observational Prospective Study to Understand the Usage Pattern of Ticagrelor With ACS (Acute Coronary Syndrome)

Study Overview
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Brief Summary
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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
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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

Official Title
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A Non-interventional Prospective Observational Study to Understand the Usage Pattern of Ticagrelor in Indian Patients With Acute Coronary Syndrome.

Conditions
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Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with medical history of intracranial hemorrhage All those patients who are not fit to receive Ticagrelor as per the latest prescribing information
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| one arm<br>patients on Ticagrelor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage pattern of Ticagrelore in real life setting | 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) | 48 Weeks | 
| Usage pattern of Ticagrelore | Assessing the proportion of patients with different types of ACS management namely, PCI, CABG and Medical Management | 48 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of various risk factors | GRACE (Global Registry of Acute Coronary Events) score | 48 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS