| CTRI Number |
CTRI/2024/11/077130 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A New formulation of drug for Heart Attack and Comparison with Pre-existing drug |
|
Scientific Title of Study
|
Comparison of clinical outcomes between patients with Acute Coronary Syndrome receiving Conventional Loading Dose and Newly formulated loading dose with Trimetazidine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAI SINDHURI MARUVADA |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no. 1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Room no. 1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
07382990519 |
| Fax |
|
| Email |
sindhu.1903@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAI SINDHURI MARUVADA |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Chennai, Tamil Nadu, India
Chennai, Tamil Nadu, India
TAMIL NADU
602105
India |
| Phone |
07382990519 |
| Fax |
|
| Email |
sindhu.1903@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAI SINDHURI MARUVADA |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Chennai, Tamil Nadu, India
Chennai, Tamil Nadu, India
TAMIL NADU
602105
India |
| Phone |
07382990519 |
| Fax |
|
| Email |
sindhu.1903@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai, Tamil Nadu 602105 |
| Type of Sponsor |
Private medical college |
|
|
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 Sai Sindhuri Maruvada |
Saveetha Medical College and Hospital |
Saveetha Nagar, Thandalam, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU |
07382990519
sindhu.1903@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Loading dose for |
Conventional Loading dose for Acute Coronary Syndrome containing Aspirin(300mg), Clopidogrel(300mg), Atorvastatin(80mg) |
| Intervention |
New formulation of Loading dose |
New formulation of Loading dose for Acute Coronary Syndrome containing Aspirin(300mg), Clopidogrel(300mg), Atorvastatin(80mg), Trimetazidine(35mg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Ability to consent
2. Patients presenting with symptoms suggestive of ACS, including chest pain or discomfort, and corresponding ECG changes indicative of ischemia or myocardial injury (ST-segment elevation, ST-segment depression, T-wave inversion).
3. Absence of contraindications to aspirin, clopidogrel, statins, and Trimetazidine, including known allergies, intolerances, or significant adverse reactions.
4. Hemodynamically stable patients, defined as those without evidence of ongoing ischemia or hemodynamic compromise requiring urgent intervention (e.g., cardiogenic shock).
|
|
| ExclusionCriteria |
| Details |
1. Age above 80 years
2. Inability to consent
3. Patients with a recent history of major bleeding events within a specified time frame, typically within the past 30 days, increasing the risk of recurrent bleeding complications with antiplatelet and anticoagulant therapy.
4. Patients presenting with hemodynamic instability requiring immediate revascularization or intensive care management, such as cardiogenic shock or acute pulmonary edema.
5. Patients with symptoms suggestive of chest pain or discomfort due to non-cardiac causes (e.g., musculoskeletal pain, gastrointestinal disorders) without evidence of ACS on diagnostic evaluation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of Major Adverse Cardiac Events using Seattle Angina Score |
1 month after administration of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life, Mortality due to Cardiac Cause, Number of hospital visits, Duration and the Number of Hospital admission |
3 months after administration of drug |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/12/2024 |
| 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="6"
Days="0" |
|
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
|
This study involves pharmacological development of oral formulation in the form of tablet with Acetyl Salicylic acid(300mg), Clopidogrel(300mg), Atorvastatin(80mg) and Trimetazidine(35mg). Following the development of the composition, Preclinical animal trial will be conducted for a period of 30 days, to assess the adverse drug reactions (ADR) of the newly developed formulation. Phase-1 clinical trial will be conducted in healthy volunteers, by administering newly developed formulation. Regular monitoring of vital signs (Heart rate, blood pressure, temperature), regular blood and urine test (Liver and kidney function test) to look for signs of toxicity will be done. Participants will be closely monitored for any adverse effects. Phase-2 clinical trial: Participants who satisfy the inclusion criteria will be randomly assigned to either of the two groups, one group receiving the Newly developed formulation and the other group receiving Conventional loading dose. To compare the efficacy of the formulation MACE(Major Adverse Cardiovascular Events), Quality of Life(Seattle Angina Questionnaire) will be assessed over 3 months duration.
|