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

AstraZeneca logo

AstraZeneca

Status

Completed

Conditions

Acute Coronary Syndrome

Study type

Observational

Funder types

Industry

Identifiers

NCT02408224
NIS-CIN-BRI-2014/1 (Other Identifier)
D5130R00029

Details and patient eligibility

About

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.

Full 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

Enrollment

3,000 patients

Sex

All

Volunteers

No 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

Trial design

3,000 participants in 1 patient group

one arm
Description:
patients on Ticagrelor

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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