CTRI/2024/03/063694 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On:
17/12/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Single Arm Study
Public Title of Study
Study to assess the Safety and efficacy of Hetero tenecteplase in the treatment of Myocardial infarction.
Scientific Title of Study
A Phase IV, Post-marketing, Prospective, Multicentre, Single Arm Clinical Study to
Evaluate the Safety, Efficacy and Immunogenicity of Hetero-Tenecteplase for
Thrombolysis in Acute Myocardial Infarction
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
HCR/IV/TENESTEMI/02/2023; Version 1.0; 06-Feb-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shubhadeep Sinha MD
Designation
Senior Vice President and Head
Affiliation
Hetero Labs Limited
Address
Clinical Development & Medical Affairs, 2nd Floor, 7-2-A2, Industrial
Estates, Sanath Nagar, Hyderabad
India
Hyderabad TELANGANA 500018 India
Phone
914023704923
Fax
914023801902
Email
sd.sinha@heterodrugs.com
Details of Contact Person Scientific Query
Name
Dr Sreenivasa Chary S
Designation
Senior General Manager
Affiliation
Hetero Labs Limited
Address
Clinical Development & Medical Affairs, 2nd Floor, 7-2-A2, Industrial
Estates, Sanath Nagar, Hyderabad
India
Hyderabad TELANGANA 500018 India
Phone
914023704923
Fax
914023801902
Email
Sreenivasa.Chary@hetero.com
Details of Contact Person Public Query
Name
Dr Subhadeep Sinha MD
Designation
Senior Vice President
Affiliation
Hetero Labs Limited
Address
Clinical Development & Medical Affairs, 2nd Floor, 7-2-A2, Industrial
Estates, Sanath Nagar, Hyderabad
Hyderabad TELANGANA 500018 India
Phone
914023704923
Fax
914023801902
Email
sd.sinha@hetero.com
Source of Monetary or Material Support
Hetero Biopharma Limited, HNO.8_3_166_1,2, 105 to 108, 1st Floor, G Block, East Wing,
Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018.
Primary Sponsor
Name
Hetero Biopharma Limited
Address
HNO.8_3_166_1,2, 105 to 108, 1st Floor, G Block, East Wing,
Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018.
Department of Cardiology, Sheikhpura, Patna-800014,Bihar, India Sheikhpura BIHAR
9431646727
rvpd2004@yahoo.co.in
Dr Sanjay Kumar Sharma
Maharaja Agrasen Superspeciality Hospital
Department of Cardiology, Central Spine, Sector -7, Vidyadhar Nagar - 302039, India Jaipur RAJASTHAN
9461011234
sanjaysharma.clinical@gmail.com
Dr Subhashis Chakraborty
NRS Medical College
Cardiology Indoor, Beside Seminar Hall, 4th Floor, 138, AJC Bose Road, Kolkata - 700014 Kolkata WEST BENGAL Kolkata WEST BENGAL
8335883600
dr.subhashis1980@gmail.com
Dr Divya Prakash M
Bangalore Medical College & Research Institute,
Department of cardiology, Victoria Hospital(PMSSY), Fort Road, KR Puram Bangalore, Karnataka Bangalore KARNATAKA
9845860473
drdivyaprakashm@gmail.com
DrManoj Kumar Bhavarilal
Chopda Medicare and Research Centre Pvt Ltd; Magnum Heart Institute
3/5 Patil Lane No.1,Laxmi Nagar, Near K.B.H Vidyalaya, Canada Corner - 422005, India. Nashik MAHARASHTRA
9823021613
drchopdamanoj@gmail.com
Dr Puneet Aggarwal
Dr.Ram Manohar Lohia Hospital, PGIMER
Room No. 206, 2nd floor, Academic Block, Baba Kharak Singh Road, Near Gurudwara Bangla Sahib, Type III, Connaught Place, New Delhi-110001 New Delhi DELHI
7235807073
puneetaggarwal4u@gmail.com
Dr N Srikanth
Government General Hospital
Department of Cardiology, Room No. 352, II Floor, Podila Prasad Superspeciality Block, Opposite Railway Station, 522001, India Guntur ANDHRA PRADESH
9492662370
nathani_7904@yahoo.co.in
Dr Rakesh Mahla
Jawahar Lal Nehru Medical College
Kala Bagh – 305001, India Ajmer RAJASTHAN
9950836000
drrakeshmahla@outlook.com
Dr P V Raghava Sarma
Lalitha Super Specialities Hospital (P) Ltd
Ground Floor,Department of Cardiology, New Building, Kothapet- 522001, India Guntur ANDHRA PRADESH
9440800355
drpvraghav@gmail.com
Dr Ajmera Prakash
Malla Reddy Narayana Multispeciality Hospital
Suraram X Roads, Jeedimetla, Hyderabad 500055, Telangana Hyderabad TELANGANA
9985401317
wglprakash@yahoo.com
Dr Biswarup Sarkar
Medical College
2nd Floor, Main Building, Near Gate 2, Department of Cardiology, 88, College Street, Kolkata, 70073, West Bengal, India Kolkata WEST BENGAL
9433113863
drsarkar16@gmail.com
DrMukund Kumbla
Omega Hospital (P) Ltd
Mahaveer Circle,Kankanady, Mangalore -575002, India Dakshina Kannada KARNATAKA
9845082811
drmukund@epsilon.net.in
Dr Soumik Chaudhuri
Peerless Hospitex Hospital and Research Center Limited
2nd Floor, Cardiology OPD, 360, Panchasayar, Kolkata – 700094, West Bengal, India
Kolkata WEST BENGAL
9830153299
dr.soumik@gmail.com
Dr Nirav Bhalani
Rhythm Heart Institute
A Unit of Synergy Lifecare Pvt. Ltd, Near Siddharth Bunglows,
390022 India Vadodara GUJARAT
8128995863
trial@rhythmheart.com
Dr Harsha MM
Sri Jayadeva of Cardio Vascular Sciences & Research
KRS Road, Mysore,570016. Mysore KARNATAKA
9839290162
drharshamm@gmail.com
Dr M Vengatesh
SRM Medical College Hospital & Research Centre
Department of Cardiology, Kattankulathur 603203, Chengalpattu, Kancheepuram, Tamil Nadu, India Kancheepuram TAMIL NADU
9840985262
vengatem@srmist.edu.in
Dr Abhishek Sachdeva
Swarooprani Motilal Nehru Medical College
Department of Cardiology, Prayagraj, Uttar Pradesh, India-211001 Allahabad UTTAR PRADESH
9990850478
drabhisheksachdeva@gmail.com
Dr J Cecily Mary Majella
Tamil Nadu Govt. Multi Super Specialty Hospital
Omandurar Govt. Estate, Chennai – 600002, Tamilnadu Chennai TAMIL NADU
944358415
drcecilym.research@gmail.com
Dr Anwar Hussain Ansari
Vardhman Mahaveer Medical College & Safdarjung Hospital
Department of Cardiology, Ansari Nagar, New Delhi- 110029 South West DELHI
Clinical Research Ethics Committee, Peerless Hospitex Hospital and Research Center Limited, 2nd Floor, Cardiology OPD, 360, Panchasayar, Kolkata – 700094, West Bengal, India.
Approved
Ethics Committee GMC & GGH
Submittted/Under Review
Ethics Committee of BMCRI, KR Road, Fort, Bengalore 560002
Approved
Ethics Committee SRM MCH & RC SRM Medical College Hospital & Research Centre
Institutional Ethics Committee, MLN Medical College
Approved
Institutional Ethics Committee, Sri Jayadeva Institute of Cardiovascular Sciences & Research Mysore Branch
Approved
Institutional Ethics Committee, TNGMSSH Tamil Nadu Govt. Multi Super Specialty Hospital
Approved
Lalitha Super Specialities Hospital Ethics Committee
Submittted/Under Review
Magna Care Ethics Committee, Chopda Medicare and Research Centre Pvt Ltd
Submittted/Under Review
Malla Reddy Medical College for Women - Institutional Ethics Committee, 2nd floor, Malla Reddy Narayana Multispeciality Hospital, Suraram X road, Jeedimetla, Hyderabad, Telangana 500055, India
Single dose of Hetero - Tenecteplase on the basis of Body weight, with a maximum dose of 10,000 units (50 mg Tenecteplase). Tenecteplase is for intravenous administration only.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Adult male and female of 18 years or above
2. Patients and willing to provide written informed consent. Consent from Legally Acceptable Representative (LAR), if patient is not in the
condition to give consent. However, when the patient is stable and is able to give consent, consent would be obtained to confirm his/her
willingness to continue in the study
3. Patients with Suspected Myocardial Infarction with Persistent ST
Elevation and/or Recent Left Bundle Branch Block (LBBB) within 6
Hours after the Onset of Acute Myocardial Infarction (AMI) Symptoms
4. Women of childbearing potential must agree to get pregnancy test done
at the time of enrolment and it should be negative.
ExclusionCriteria
Details
1. Patients contraindicated or with history/evidence of hypersensitivity to
thrombolytics or any of the components of formulation.
2. Patients with history/ active internal active bleeding or hemorrhagic
3. Patients with history of cerebrovascular accident
4. History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or intra spinal surgery or trauma within the past 2
months
5. Uncontrolled hypertension (systolic BP LTN 180 mmHg or diastolic BP GRTN 110 mmHg).
6. Where, in the opinion of the investigator, participation in this study will
not be in the best interest of the subject, or any other circumstances that
prevent the subject from participating in the study safely.
7. If the patient participated in any clinical trials or clinical usage
involving Tenecteplase, Alteplase or other anti-thrombolytic drugs prior
to one year of enrolment.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Incidence, severity, outcome, duration, action taken, and causality of
individual adverse events [Labelled/Unlabelled and Serious/Non-
Serious] reported during the study
180 days
Secondary Outcome
Outcome
TimePoints
Incidence, severity, outcome of Adverse Events of Special Interest
Internal bleeding, involving intracranial and retroperitoneal sites, or the
gastrointestinal, genitourinary, or respiratory tracts.
Superficial or surface bleeding, observed mainly at vascular puncture and access
sites (e.g., venous cutdowns, arterial punctures) or sites of recent surgical
intervention.
Cholesterol Embolization
Cardiac Arrhythmias
90 minutes
Thromboembolic episodes.
Proportion of patients with Clinically Evident Successful Thrombolysis (Defined as
significant relief in chest pain and resolution of the ST-segment elevation on the ECG
or ≥50% resolution of elevated ST segment
90 min, 24, 48, 30 days, 60 days and 90 days
Mortality rate
30 days, 60 days and 90 days and 180 days
Immunogenicity assessment at Baseline
30 days, 90 days or end of the study, if earlier
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Post-marketing, Prospective, Multicentre,
Single Arm Clinical Study to evaluate the safety, efficacy and
immunogenicity of intravenous injection Tenecteplase (Hetero Biopharma Limited)
in adult patients of suspected myocardial infarction with persistent ST
elevation.
Patients will be screened for study eligibility based on the
inclusion and exclusion criteria. Patients eligible for the study will be
enrolled and administered Hetero-Tenecteplase. All patients shall be
administered on the basis of body weight, with a maximum dose of 10,000 units
i.e., 50 mg of Tenecteplase. All patients will be followed up for 30 days, 60
days and 90 days for efficacy and safety assessments, then there will be safety
follow up at 6 months. The study is
expected to be completed in approximately 12 - 18 months after dosing of the
first patient.