Clinical trial NCT02408224: An Observational Prospective Study to Understand the Usage Pattern of Ticagrelor With ACS (Acute Coronary Syndrome)
Official title: A Non-interventional Prospective Observational Study to Understand the Usage Pattern of Ticagrelor in Indian Patients With Acute Coronary Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: ACS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male/female with Acute Coronary Syndrome on Ticagrelor on discharge or ≤ 1month

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

Eligibility criteria: 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

Primary outcomes:
measure: Usage pattern of Ticagrelore in real life setting
timeFrame: 48 Weeks
measure: Usage pattern of Ticagrelore
timeFrame: 48 Weeks
Secondary outcomes:
measure: Frequency of various risk factors
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Research Site
state: Andhra Pradesh
city: Patna
country: India
facility: Research Site
state: Bihar
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Rajkot
country: India
facility: Research Site
state: Gujarat
city: Surat
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Gurgaon
country: India
facility: Research Site
state: Haryana
city: Srinagar
country: India
facility: Research Site
state: Jammu And Kashmir
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Bengaluru
country: India
facility: Research Site
state: Karnataka
city: Mysore
country: India
facility: Research Site
state: Karnataka
city: Kolenchery
country: India
facility: Research Site
state: Kerala
city: Thrissur
country: India
facility: Research Site
state: Kerala
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nasik
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: Bhubaneswar
country: India
facility: Research Site
state: Odisha
city: Ludhiana
country: India
facility: Research Site
state: Punjab
city: Mohali
country: India
facility: Research Site
state: Punjab
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Hyderabad
country: India
facility: Research Site
state: Telangana
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Noida
country: India
facility: Research Site
state: Uttar Pradesh
city: Durgapur
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
Study officials:
affiliation: Sir Ganga Ram Hospital, Delhi
name: JP S Sawhney, MBBS, MD, DM
role: STUDY_CHAIR
affiliation: AstraZeneca Pharma India Ltd
name: Bhavesh P Kotak, MBBS MD
role: STUDY_DIRECTOR
References:
citation: 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.