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NCT02408224 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

— TREASURE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02408224
Other study ID # D5130R00029
Secondary ID NIS-CIN-BRI-2014
Status Completed
Phase
First received
Last updated
Start date April 27, 2015
Est. completion date June 24, 2017

Study information
Verified date June 2018
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 3000
Est. completion date June 24, 2017
Est. primary completion date June 24, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Written informed consent has been provided.

2. Aged 18 years or older.

3. Male/female with ACS on Ticagrelor on discharge or = 1month.

4. Patient underwent PCI, CABG or MM (Medical Management) for ACS.

5. Diagnosis of STEMI, NSTEMI or UA

Exclusion Criteria:

1. Patients with medical history of intracranial hemorrhage

2. All those patients who are not fit to receive Ticagrelor as per the latest prescribing information

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Research Site Ahmedabad Gujarat
India Research Site Bangalore Karnataka
India Research Site Bengaluru Karnataka
India Research Site Bhubaneswar Odisha
India Research Site Chennai Tamil Nadu
India Research Site Coimbatore Tamil Nadu
India Research Site Delhi New Delhi
India Research Site Durgapur West Bengal
India Research Site Gurgaon Haryana
India Research Site Hyderabad Andhra Pradesh
India Research Site Hyderabad Telangana
India Research Site Jaipur Rajasthan
India Research Site Kolenchery Kerala
India Research Site Kolkata West Bengal
India Research Site Lucknow Uttar Pradesh
India Research Site Ludhiana Punjab
India Research Site Madurai Tamil Nadu
India Research Site Mohali Punjab
India Research Site Mumbai Maharashtra
India Research Site Mysore Karnataka
India Research Site Nasik Maharashtra
India Research Site New Delhi Delhi
India Research Site Noida Uttar Pradesh
India Research Site Patna Bihar
India Research Site Pune Maharashtra
India Research Site Rajkot Gujarat
India Research Site Srinagar Jammu And Kashmir
India Research Site Surat Gujarat
India Research Site Thrissur Kerala
India Research Site Vadodara Gujarat
India Research Site Vijayawada Andhra Pradesh

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Usage pattern of Ticagrelore Assessing the proportion of patients with different types of ACS management namely, PCI, CABG and Medical Management 48 Weeks
Secondary Frequency of various risk factors GRACE (Global Registry of Acute Coronary Events) score 48 Weeks
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