| CTRI Number |
CTRI/2024/07/069720 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Anti-Anginal Effectiveness of Trimetazidine 60 mg Once Daily in Stable Angina Patients |
|
Scientific Title of Study
|
A Prospective, Multicenter, Open-label, Post-Marketing Observational Study to Evaluate the Anti-Anginal Effectiveness of Trimetazidine 60 mg Once Daily Formulation in Stable Angina Patients in Real-World Practice
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TRTA-523-0453, Version-Final 1.0, Date-21 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arindam Pande |
| Designation |
Principal Investigator |
| Affiliation |
Medica super speciality hospital |
| Address |
127 Mukundapur, E M Bypass,
Kolkata
WEST BENGAL
700099
India |
| Phone |
9830686081 |
| Fax |
|
| Email |
drapande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswhini Pawar |
| Designation |
Director Medical Affairs |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
Floor 17, Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
7710004176 |
| Fax |
|
| Email |
ashwini.pawar@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Associate Director Clinical Development & Operation |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra
(E),
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Private Limited
Floor 17, Godrej BKC Plot No C 68 BKC Near MCA Club,
Bandra (E), Mumbai, MAHARASHTRA 400051 India |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Private Limited |
| Address |
17th Floor, Godrej BKC
Bandra (E) Mumbai - 400 051, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Abhishek Shukla |
Ajanta Hospital and IVF Centre, |
765, ABC Complex, Kanpur Road, Alambagh, 226005
Lucknow
UTTAR PRADESH |
8887987104
abhishekkshukla1984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ajnata Hospital and IVF centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I209||Angina pectoris, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Trimetazidine 60 mg, |
Once Daily, Capsule, Route of administration-Oral,
Duration-03 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The subjects will be included in the study based on the following criteria:
1. Male/female of ≥ 18 years of age.
2. Patient diagnosed with CSA by HCP (health care professional) and Prescribed Trimetazidine 60 mg OD as per HCP’s discretion.
3. Patient willing to give written informed consent to participate into the study.
4. Willing to take the study drug as prescribed by the investigator.
5. Willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
A patient will be excluded from the study if they meet any of the following criteria:
1. Known hypersensitivity to Trimetazidine or excipients of the formulation.
2. Parkinson’s disease, parkinsonian symptoms, tremors, restless leg syndrome and other related movement disorders.
3. Known case of severe renal impairment.
4. Any other condition/ uncontrolled co-morbid conditions that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
5. Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in the mean number of weekly angina attacks from baseline to 3 months.
2. Change in number of short acting nitrates consumed per week from baseline to 3 months. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of ADR/OPRI during the study period.
2. Measure patient characteristics like age, gender, comorbidities, medical and personal history and past treatment history of patients.
3. Analyze the co-prescription data with Trimetazidine. |
3 months. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/07/2024 |
| 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="0"
Months="3"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Post-Marketing Observational Study to Evaluate the Anti-Anginal Effectiveness of Trimetazidine 60 mg Once Daily in Stable Angina Patients. approximately on 160 patients from approximately 10 clinical sites.There are three visits in the study and study duration is of 90 days +/- 3 days window period. |