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NCT Number: NCT02408224

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Hyderabad, Andhra Pradesh, India

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Usage pattern of Ticagrelore in real life setting

    Time frame: 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)

  2. Usage pattern of Ticagrelore

    Time frame: 48 Weeks

    Assessing the proportion of patients with different types of ACS management namely, PCI, CABG and Medical Management

Secondary outcomes

  1. Frequency of various risk factors

    Time frame: 48 Weeks

    GRACE (Global Registry of Acute Coronary Events) score

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: TREASURE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2015
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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