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

NCT ID: NCT02408224

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-27

Study Completion Date

2017-06-24

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

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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one arm

patients on Ticagrelor

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JP S Sawhney, MBBS, MD, DM

Role: STUDY_CHAIR

Sir Ganga Ram Hospital, Delhi

Bhavesh P Kotak, MBBS MD

Role: STUDY_DIRECTOR

AstraZeneca Pharma India Ltd

Locations

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Research Site

Hyderabad, Andhra Pradesh, India

Site Status

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Vijayawada, Andhra Pradesh, India

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Patna, Bihar, India

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Ahmedabad, Gujarat, India

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Rajkot, Gujarat, India

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Surat, Gujarat, India

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Vadodara, Gujarat, India

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Gurgaon, Haryana, India

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Srinagar, Jammu and Kashmir, India

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Bangalore, Karnataka, India

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Bengaluru, Karnataka, India

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Mysore, Karnataka, India

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Kolenchery, Kerala, India

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Thrissur, Kerala, India

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Mumbai, Maharashtra, India

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Nashik, Maharashtra, India

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Pune, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Delhi, New Delhi, India

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Bhubaneswar, Odisha, India

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Ludhiana, Punjab, India

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Mohali, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Hyderabad, Telangana, India

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Lucknow, Uttar Pradesh, India

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Noida, Uttar Pradesh, India

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Durgapur, West Bengal, India

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Kolkata, West Bengal, India

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Countries

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India

References

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Sawhney JPS, Dalal J, Mullasari A, Bansal S, Kahali D. Therapeutic experience of ticagrelor in Indian patients with acute coronary syndrome: A non-interventional, prospective, and observational study. Indian Heart J. 2019 Jul-Aug;71(4):344-349. doi: 10.1016/j.ihj.2019.08.001. Epub 2019 Aug 30.

Reference Type DERIVED
PMID: 31779864 (View on PubMed)

Related Links

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Other Identifiers

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NIS-CIN-BRI-2014/1

Identifier Type: OTHER

Identifier Source: secondary_id

D5130R00029

Identifier Type: -

Identifier Source: org_study_id

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