CTRI/2021/06/034322 [Registered on: 21/06/2021] Trial Registered Prospectively
Last Modified On:
18/11/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Clinical Study to Test the Effectiveness and Side Effects of Hetero-Tenecteplase in Adult patients with Suspected Myocardial Infarction
Scientific Title of Study
A Prospective, Multicenter, Randomized, Comparative, Parallel Group Clinical Study to Compare The Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Intravenous Injection of Tenecteplase (Hetero Biopharma Limited) and Reference Medicinal Product (RMP-Tenecteplase, Boehringer Ingelheim) in Adults for the Thrombolytic Treatment of Suspected Myocardial Infarction with Persistent ST Elevation
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
HCR/III/TENESTEMI/08/2020; Version 1.0 Dated 05-08-2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Sreenivasa Chary S
Designation
General Manager
Affiliation
Hetero Drugs Limited
Address
Clinical Development and Medical Affairs, 2nd Floor,
7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar
Hyderabad TELANGANA 500018 India
Phone
04023704923
Fax
Email
sreenivasa.chary@heterodrugs.com
Details of Contact Person Public Query
Name
Dr Shubhadeep Sinha
Designation
Sr. Vice President
Affiliation
Hetero Drugs Limited
Address
Clinical Development and Medical Affairs, 2nd Floor, 7-2-A2, Industrial Estates, Sanath Nagar
Hyderabad TELANGANA 500018 India
Phone
040-23704923
Fax
040-23801902
Email
sd.sinha@heterodrugs.com
Source of Monetary or Material Support
Hetero Biopharma Limited, H. No. 8-3-166/1,2, 105 to 108, 1st Floor, G Block, East Wing, Challa
Estates, Erragadda, Hyderabad, Telangana, India, 500018. Tel No. and Fax No.: 914023810110
Primary Sponsor
Name
Hetero Biopharma Limited
Address
Hetero Biopharma Limited, H. No. 8-3-166/1,2, 105 to 108, 1st Floor,
G Block, East Wing, Challa Estates, Erragadda, Hyderabad,
Telangana, India, 500018. Tel No. and Fax No.: 914023810110
Ethics Committee of BMCRI, Bangalore Medical College and Research Institute
Submittted/Under Review
Ethics Committee of Dr. Ram Manohar Lohia Institute of Medical Sciences
Submittted/Under Review
Ethics Committee, N.R.S. Medical College
Submittted/Under Review
Ethics Committee, PGIMER, Dr. Ram Manohar Lohia Hospital, Baba Khadakh Singh Marg, Near Gurudwara Bangla Sahib, Type III, Cannaught Place, New Delhi - 110001
Submittted/Under Review
Ethics Committee,S.M.S. Medical College and Attached Hospitals,
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.
Comparator Agent
RMP-Tenecteplase
Single dose of RMP-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
65.00 Year(s)
Gender
Both
Details
1. Adult male or female patients of age 18-65 years (both inclusive)
2. Patient 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. Patient presenting with chest pain and/or symptoms of Acute Myocardial Infarction with ST elevation in at least 2 or more contiguous leads (12 Lead ECG) with the following:
a. ST elevation of ≥0.25 mV in men <40 years or ≥0.2 mV in men ≥40 years or ≥0.15 mV in women in leads V2-V3
AND/OR
b. ST elevation of ≥0.1 mV in other contiguous chest leads or limb leads
4. Patient presenting with AMI within 6 hours of occurrence of symptoms
5. Female patient of childbearing potential must agree to get pregnancy test done at the time of enrolment and it should be negative.
ExclusionCriteria
Details
1. Patient with new onset Left Bundle Branch Block (LBBB)
2. Patient with history/evidence of hypersensitivity to thrombolytics or any of the components of formulation including gentamicin
3. Patient planned for primary percutaneous coronary intervention (PCI).
4. Patient receiving oral anticoagulant treatments with INR >1.3
5. Patient with history of prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks
6. Patient with history/ active internal bleeding disorder within 6 months
7. Patient with history of recent gastrointestinal or genitourinary bleeding (within the past 10 days)
8. Patient with known hemorrhagic diathesis
9. Patient with known history of hemorrhagic stroke or stroke of unknown origin
10. Patient with history of ischemic stroke or transient ischemic attack in the preceding 6 months
11. Patient with history of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or spinal surgery
12. Patient of known arterial/venous malformations
13. Patient with history of trauma to the head or cranium within 6 months
14. Patient with history of major surgery, parenchymal biopsy, ocular surgery and/or significant trauma within the past 2 months (this includes any trauma associated with the current AMI).
15. Patient of uncontrolled hypertension of systolic BP >160 mm of Hg and diastolic BP >110 mm of Hg
16. Patient administered Tenecteplase in the last 14 days prior to screening.
17. Patient administered of any glycoprotein IIb/IIIa inhibitor (including abciximab, eptifibatide, sibrafiban and tirofiban) in the 24 hours prior to screening.
18. Patient with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction.
19. Patient with high risk as per TIMI risk scoring.
20. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
On-site computer system
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Rate of TIMI grade 3 flow (Thrombolysis In Myocardial Infarction) of the infarct related artery
At 90 minutes
Secondary Outcome
Outcome
TimePoints
50% resolution of elevated ST segment
At day 7, 14 and 30 or EOS if its earlier
All cause 30 day mortality rate
Day 30
Changes in left ventricular ejection fraction assessed by 2D-Echocardiography
At day 7, 14 and 30 or EOS if its earlier
Events of ventricular tachyarrhythmias
At day 7, 14 and 30 or EOS if its earlier
Pharmacokinetic parameters comparisons of Cmax, AUC0-t and AUC0-inf
After Single Dose Administration
Change in cardiac enzymes level
At hours 24 and 48
Immunogenicity assessment
At baseline and day 30 or EOS, if its earlier
Treatment emergent adverse events (clinical and laboratory)
Throughout the study period
Events of myocardial re-infarction(s)
At day 7, 14 and 30 or EOS if its earlier
Target Sample Size
Total Sample Size="198" Sample Size from India="198" Final Enrollment numbers achieved (Total)= "198" Final Enrollment numbers achieved (India)="198"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a multicentric, prospective, double blind, active control, randomized, comparative, parallel, clinical study to compare the efficacy, pharmacokinetics, pharmacodynamics, immunogenicity and safety of intravenous injection of Tenecteplase (Hetero Biopharma Limited) and Reference Medicinal Product (RMP-Tenecteplase, Boehringer Ingelheim) in adults patients with 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 randomized to either Hetero-Tenecteplase or RMP-Tenecteplase based on the randomization schedule. 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 for efficacy and safety assessments. The study is expected to be completed in approximately 8 - 12 months after dosing of the first patient.