| CTRI Number |
CTRI/2025/08/093318 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to understand clinical utility of Ticagrelor in cardiac disorder. |
|
Scientific Title of Study
|
A retrospective, Cross-sectional study on Ticagrelor usage pattern and
tolerability in acute coronary syndrome (CROSS-TIC) |
| Trial Acronym |
CROSS-TIC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2502104, Version- 00, Dated- 07/05/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Gabhane |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000639 |
| Fax |
|
| Email |
mukeshgabhane@torrentpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Gabhane |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India
GUJARAT
380009
India |
| Phone |
7069000639 |
| Fax |
|
| Email |
mukeshgabhane@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Gabhane |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India
GUJARAT
380009
India |
| Phone |
7069000639 |
| Fax |
|
| Email |
mukeshgabhane@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd.
Off. Ashram Road, Terapanth Rd, Navrangpura, Ahmedabad, Gujarat 380009 |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Off. Ashram Road, Terapanth Rd, Navrangpura, Ahmedabad, Gujarat 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tarun Dave |
Heart Beat Clinic |
24, Second Floor, White House, Panchavati Society, Ambawadi, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT |
9824039416
tpl.sitemanagement@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I200||Unstable angina, (2) ICD-10 Condition: I21||Acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients 18 years and above
2. Patients with history of MI or diagnosed with ACS and treated with ticagrelor |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Proportion of patients with ACS on DAPT of ticagrelor and aspirin |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients with ACS on DAPT of ticagrelor & aspirin stratified by treatment duration
2. Tolerability |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="15000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute Coronary Syndrome (ACS) is a life-threatening clinical condition resulting from acute myocardial ischemia, encompassing unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). It is most commonly caused by atherosclerotic plaque rupture with subsequent thrombosis and platelet aggregation, necessitating prompt antiplatelet therapy. Dual antiplatelet therapy (DAPT), typically involving aspirin and a P2Y12 receptor inhibitor, is the cornerstone of ACS management. While clopidogrel is widely used, its limitations have led to the use of newer agents like prasugrel and ticagrelor. This retrospective, clinic-based drug utilization study aims to assess the usage pattern and tolerability of ticagrelor in the management of ACS or in patients with a prior history of myocardial infarction. The study will analyze approximately 15,000 cases across India to better understand ticagrelor’s real-world application and impact in secondary cardiovascular event prevention. Data of male or female patients 18 years and above and patients with history of MI or diagnosed with ACS and treated with ticagrelor will be collected for the study. |