| CTRI Number |
CTRI/2024/08/072100 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Evaluate the Effectiveness of Deferiprone Capsules in Patients Recovering from a Recent Heart Attack |
Scientific Title of Study
Modification(s)
|
A Prospective, Multicenter, Single-arm, Open Label, Study to Determine Cardiac MRI-Guided Deferiprone Therapy for Acute Myocardial Infarction Patients. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 07/24/DFP, Version 2.0 (18/03/2025) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kinjal Bhatt |
| Designation |
Principal Investigator |
| Affiliation |
Synergy Superspecialty Hospital |
| Address |
1st Floor,OPD room 03, Cardiology department,150 feet ring road, Opposite Gokul Mathura Apartment, Ayodhya Chowk, Rajkot 360005, Gujarat,INDIA
Rajkot
GUJARAT
360005
India |
| Phone |
02816195050 |
| Fax |
|
| Email |
medical.admin@synergyhospital.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kinjal Bhatt |
| Designation |
Principal Investigator |
| Affiliation |
Synergy Superspecialty Hospital |
| Address |
1st Floor,OPD room 03, Cardiology department,150 feet ring road, Opposite Gokul Mathura Apartment, Ayodhya Chowk, Rajkot 360005, Gujarat INDIA
Rajkot
GUJARAT
360005
India |
| Phone |
02816195050 |
| Fax |
|
| Email |
medical.admin@synergyhospital.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Amardeep Sharma |
| Designation |
CEO |
| Affiliation |
Eccentric Clinical Research Private Limited |
| Address |
3rd Floor, 305, KESAVAM SQAURE, OPP. RAO WORLD, Kudasan, Gandhinagar -382421, Gujarat (India)
Gandhinagar
GUJARAT
382421
India |
| Phone |
7309300319 |
| Fax |
|
| Email |
amardeep.sharma@eccentriccr.com |
|
|
Source of Monetary or Material Support
|
| Synergy Superspecialty Hospital, Ayodhya Chowk, Opposite Gokul Mathura Apartment, 150 feet ring road, Rajkot - 360005, Gujarat - INDIA |
|
|
Primary Sponsor
|
| Name |
Synergy Superspecialty Hospital |
| Address |
Ayodhya Chowk, Opposite Gokul Mathura Apartment, 150 feet ring road, Rajkot - 360005, Gujarat - INDIA |
| Type of Sponsor |
Other [Multispecialty Hospital ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Joshi |
Bharati Vidyapeeth Medical College and Hospital |
Clinical Pharmacology trial Unit Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital, Sangli, Sangli Miraj Road, Wanalesawadi Sangli, Maharashtra,416416.
Sangli
MAHARASHTRA |
9767460308
dramitjoshi@gmail.com |
| Dr KamleshKumar Thakkar |
Galaxy Heart Institue & Multispeciality Hospital |
2nd & 3rd Floor, A Block,Joyos Hubtown, B K Road,Modhera Cross Road, Mehsana 384002, Gujarat
Mahesana
GUJARAT |
9998885186
galaxy.iec1@gmail.com |
| Dr Ronak Shah |
J K Orthopaedic Hospital |
1st Floor,Consulting Room 2,OPD area,Behind Mehta Petrol Pump, Girdharnagar, Himmatnagar383001, Gujarat
Sabar Kantha
GUJARAT |
9913701470
ronak.taj@gmail.com |
| Dr Alok Ranjan |
Kiran Multi Super Speciality Hospital and Research Center |
Vasta Devdi Road, Near Sumul Dairy, Surat - 395004
Surat
GUJARAT |
9265456220
dralokranjan@outlook.in |
| Dr Abhishek Raval |
N.M.Virani Wockhardt Hospital |
Cardiology Department, Kalawad Road
Rajkot
GUJARAT |
02816694444
docabs4u@gmail.com |
| Dr JayKumar Sanghavi |
NamostuTe Hospital |
Plot No-1285 Sector-6 D Near GH-3 circle opposite civil hospital, Gandhinagar-382006
Gandhinagar
GUJARAT |
9974310230
dr.jaykumarsanghavi.cr@gmail.com |
| Dr Nirav Bhalani |
Rhythm Heart Institute |
Rhythm Heart Institute, Near Siddharth Bungalows, Sama Savli Road,
Vadodara
GUJARAT |
9727166471
trial@rhythmheart.com |
| Dr Bonny Gajjar |
SCAI Superspeciality Hospitals |
001/002 Ground Floor, Corporate Unit, Siddhraj Z2, Near SCAI Hospitals Circle, Kudasan, Gandhinagar, Gujarat 382419
Gandhinagar
GUJARAT |
8980009499
gajjarbonny@gmail.com |
| Dr Kinjal Bhatt |
Synergy Superspeciality Hospital |
1st Floor, OPD room 03, Cardiology department,150 feet ring road, Opposite Gokul Mathura Apartment, Ayodhya Chowk, Rajkot 360005, Gujarat
Rajkot
GUJARAT |
02816195050
medical.admin@synergyhospital.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Galaxy Institutional Ethics Committee |
Approved |
| IEC, N M Virani Wockhardt Hospital |
Approved |
| IEC, Shashvat Surgicare Hospital |
Approved |
| Institutional Ethics Committee BVDU Medical College and Hospital |
Approved |
| J K Orthopaedic Hospital Ethics Committee |
Approved |
| Kiran Hospital Ethics Committee |
Approved |
| Rhythm Heart Institute Ethics Committee |
Approved |
| Sushrusha Navneet Memorial Hospital Ethics Committee |
Approved |
| Synergy Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deferiprone |
Deferiprone
Dose 500 mg and 250 mg Capsules given TID as per Body weight
Duration 60 Days
Mode of Administration Oral
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient of either gender, aged 18 to 75 years (both inclusive)
2)Patient with no physical limitation to ingest and retain oral medication
3)New or newly diagnosed patients with ST Elevation Myocardial Infarction (STEMI) confirmed by electrocardiogram (ECG)
4)Patients recently underwent primary Percutaneous Coronary Intervention (PCI)
5)Patients who understand & willing to comply with study requirements and provide written informed consent for participation
6)Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy
|
|
| ExclusionCriteria |
| Details |
1)Prior history of MI / PCI / coronary artery bypass graft (CABG)
2)Patients with previous history of left ventricular ejection fraction less then 40%
3)Patients with eGFR less than 30 ml/min/1.73m2 at screening.
4)Patients with Absolute Neutrophil Count (ANC) less than 1.0 x 109 /L at screening
5)Elevated hepatic enzymes like Alkaline phosphatase (ALT) and/or aspartate aminotransferase (AST) more than 2 times of upper normal limit and not taking medications for chronic liver disease.
6)Patients with Body weight more than 140 kg (or 309 lbs.) at screening
7)Any contraindication against cardiac MRI (such as metal implants etc.) and known allergy or contra-indication to gadolinium/contrast agents.
8)Patients with heme storage disease (hemochromatosis, thalassemia) or who are already treated with heme deactivators.
9)Patient with history of HIV and or Hepatitis B and or Hepatitis C.
10)Participation in any experimental drug and or device study within 60 days before screening.
11)Any clinically significant abnormality identified prior to enrollment in the judgment of the Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone.
12)Life expectancy of less than 1 year due to noncardiac pathology.
13)The presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may affect the study outcome parameter data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess the Percentage reduction of hemorrhagic zone heme content by using Late Gadolinium Enhancement (LGE) contrast based Cardiac Magnetic Resonance Imagining (MRI) T2 mapping weighted images and quantification
2)To assess the Percentage changes in Infarct Size and Left Ventricular Ejection Fraction (LVEF) using Late Gadolinium Enhancement (LGE) contrast based Cardiac MRI |
Baseline and Day 90 ± 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events & serious adverse events |
From Baseline to Day 90 ± 3 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/08/2024 |
| 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
Modification(s)
|
Years="1"
Months="6"
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
Modification(s)
|
This prospective Investigator Initiated Trial (IIT) study, multicenter, single arm, open-label study aims to evaluate Cardiac MRI-guided Deferiprone therapy for acute myocardial infarction (MI) patients. The study will commence at each site following Ethics Committee (EC) approval. 30 Newly diagnosed STEMI patients who have recently undergone PCI will be approached for the screening procedure. Written informed consent will be obtained before any study-related procedures by the clinical site team are performed.
This study will be conducted in compliance with the Protocol, Good Clinical Practice (GCP) as set forth in the International Council for Harmonization (ICH) guidelines on GCP (ICH E6 (R3)) and applicable local regulatory requirements |