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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02408224

Acronym

TREASURE

Enrollment

3000

Registered

2015-04-03

Start date

2015-04-27

Completion date

2017-06-24

Last updated

2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

ACS

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Frequency of various risk factors	48 Weeks	GRACE (Global Registry of Acute Coronary Events) score

Countries

India

Outcome results