Acute Coronary SyndromeTREASURENCT02408224
An Observational Prospective Study to Understand the Usage Pattern of Ticagrelor With ACS (Acute Coronary Syndrome)
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 31 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 3,000 participants
- Where
- 31 sitesIndia
- Study dates
- 27 Apr 2015to 24 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male/female with Acute Coronary Syndrome on Ticagrelor on discharge or ≤ 1month
Who may be able to join
- 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
Who cannot join
- Patients with medical history of intracranial hemorrhage
- All those patients who are not fit to receive Ticagrelor as per the latest prescribing information
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
India31 sites
Research Site
Ahmedabad, Gujarat
Research Site
Bangalore, Karnataka
Research Site
Bengaluru, Karnataka
Research Site
Bhubaneswar, Odisha
Research Site
Chennai, Tamil Nadu
Research Site
Coimbatore, Tamil Nadu
Research Site
Delhi, New Delhi
Research Site
Durgapur, West Bengal
Research Site
Gurgaon, Haryana
Research Site
Hyderabad, Andhra Pradesh
Research Site
Hyderabad, Telangana
Research Site
Jaipur, Rajasthan
Research Site
Kolenchery, Kerala
Research Site
Kolkata, West Bengal
Research Site
Lucknow, Uttar Pradesh
Research Site
Ludhiana, Punjab
Research Site
Madurai, Tamil Nadu
Research Site
Mohali, Punjab
Research Site
Mumbai, Maharashtra
Research Site
Mysore, Karnataka
Research Site
Nashik, Maharashtra
Research Site
New Delhi, National Capital Territory of Delhi
Research Site
Noida, Uttar Pradesh
Research Site
Patna, Bihar
Research Site
Pune, Maharashtra
Research Site
Rajkot, Gujarat
Research Site
Srinagar, Jammu and Kashmir
Research Site
Surat, Gujarat
Research Site
Thrissur, Kerala
Research Site
Vadodara, Gujarat
Research Site
Vijayawada, Andhra Pradesh
About this study
Official title: A Non-interventional Prospective Observational Study to Understand the Usage Pattern of Ticagrelor in Indian Patients With 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.
Read the 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
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| one arm | patients on Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 Weeks
Usage pattern of Ticagrelore
Assessing the proportion of patients with different types of ACS management namely, PCI, CABG and Medical Management
Measured: 48 Weeks
Secondary outcomes (1)
Frequency of various risk factors
GRACE (Global Registry of Acute Coronary Events) score
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study start27 Apr 2015
- Primary completion24 Jun 2017
- Study completion24 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JP S Sawhney, MBBS, MD, DM, Study chair, Sir Ganga Ram Hospital, DelhiBhavesh P Kotak, MBBS MD, Study director, AstraZeneca Pharma India Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408224
- Sponsor's protocol ID
- D5130R00029
- Other IDs
- NIS-CIN-BRI-2014/1
- Acronym
- TREASURE
- Status last verified
- Jun 2018
- First submitted
- 31 Mar 2015
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31779864
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Prospective Observational Study to Understand the Usage Pattern of Ticagrelor in Indian Patients With Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT02408224
- Acronym / sponsor ID
- TREASURE / D5130R00029
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 24 Jun 2017 (actual)
- Study completion
- 24 Jun 2017 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm | – | –patients on Ticagrelor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male/female with Acute Coronary Syndrome on Ticagrelor on discharge or ≤ 1month
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with medical history of intracranial hemorrhage
- All those patients who are not fit to receive Ticagrelor as per the latest prescribing information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
1 secondary outcome
Frequency of various risk factors
Time frame: 48 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 31779864Sawhney 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.
- Revised CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JP S Sawhney, MBBS, MD, DM study chair
Sir Ganga Ram Hospital, Delhi
Bhavesh P Kotak, MBBS MD study director
AstraZeneca Pharma India Ltd
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 31 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage pattern of Ticagrelore in real life setting (time frame: 48 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.