NCT02408224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

April 27, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2017

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

2.2 years

First QC Date

March 31, 2015

Last Update Submit

June 21, 2018

Conditions

Keywords

ACS

Outcome Measures

Primary Outcomes (2)

  • 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

  • Usage pattern of Ticagrelore

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

    48 Weeks

Secondary Outcomes (1)

  • Frequency of various risk factors

    48 Weeks

Study Arms (1)

one arm

patients on Ticagrelor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male/female with Acute Coronary Syndrome on Ticagrelor on discharge or ≤ 1month

You may qualify if:

  • 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

You may not qualify if:

  • Patients with medical history of intracranial hemorrhage
  • All those patients who are not fit to receive Ticagrelor as per the latest prescribing information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Research Site

Hyderabad, Andhra Pradesh, India

Location

Research Site

Vijayawada, Andhra Pradesh, India

Location

Research Site

Patna, Bihar, India

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Research Site

Ahmedabad, Gujarat, India

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Research Site

Rajkot, Gujarat, India

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Research Site

Surat, Gujarat, India

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Research Site

Vadodara, Gujarat, India

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Research Site

Gurgaon, Haryana, India

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Research Site

Srinagar, Jammu and Kashmir, India

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Research Site

Bangalore, Karnataka, India

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Research Site

Bengaluru, Karnataka, India

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Research Site

Mysore, Karnataka, India

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Research Site

Kolenchery, Kerala, India

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Research Site

Thrissur, Kerala, India

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Research Site

Mumbai, Maharashtra, India

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Research Site

Nashik, Maharashtra, India

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Research Site

Pune, Maharashtra, India

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Research Site

New Delhi, National Capital Territory of Delhi, India

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Research Site

Delhi, New Delhi, India

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Research Site

Bhubaneswar, Odisha, India

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Research Site

Ludhiana, Punjab, India

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Research Site

Mohali, Punjab, India

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Research Site

Jaipur, Rajasthan, India

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Research Site

Chennai, Tamil Nadu, India

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Research Site

Coimbatore, Tamil Nadu, India

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Research Site

Madurai, Tamil Nadu, India

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Research Site

Hyderabad, Telangana, India

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Research Site

Lucknow, Uttar Pradesh, India

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Research Site

Noida, Uttar Pradesh, India

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Research Site

Durgapur, West Bengal, India

Location

Research Site

Kolkata, West Bengal, India

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • JP S Sawhney, MBBS, MD, DM

    Sir Ganga Ram Hospital, Delhi

    STUDY CHAIR
  • Bhavesh P Kotak, MBBS MD

    AstraZeneca Pharma India Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

April 27, 2015

Primary Completion

June 24, 2017

Study Completion

June 24, 2017

Last Updated

June 25, 2018

Record last verified: 2018-06

Locations