CTRI/2021/06/034395 [Registered on: 25/06/2021] Trial Registered Prospectively
Last Modified On:
16/06/2025
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 comparative clinical study to evaluate efficacy and safety of test drug in patients with Acute Ischemic stroke
Scientific Title of Study
A prospective, multi-center, randomized, parallel group, two arm, active control, open label, clinical study to evaluate efficacy and safety of Tenecteplase/R-TPR-012 (0.25 mg/kg) compared with Tenectaseâ„¢ (0.20 mg/kg) in patients with Acute Ischemic stroke
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Ajay Kumar Yadav
Designation
Head - Clinical Research Services
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai - 400701, Thane MAHARASHTRA, India
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai - 400701, Thane MAHARASHTRA, India
RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai - 400701, Thane MAHARASHTRA, India
Thane MAHARASHTRA 400701 India
Phone
9820617721
Fax
Email
ganesh1.bagul@relbio.com
Source of Monetary or Material Support
Reliance Life Sciences Pvt Ltd., Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai - 400701, Maharashtra, India
Primary Sponsor
Name
Reliance Life Sciences Pvt Ltd
Address
Dhirubhai Ambani Life Sciences Centre (DALC), R-282, TTC Area of MIDC, Rabale, Navi Mumbai – 400701, Maharashtra, India
Asopa Ethics Committee, Asopa Hospital, 93 B, tagore Nagar, Near DCM, Ajmer Road, Jaipur India
Approved
Asopa Ethics Committee, Asopa Hospital, 93 B, tagore Nagar, Near DCM, Ajmer Road, Jaipur India
Approved
Dr. BAMRS Dr. Hegdewar Hiospital Ethics Committee, Dr. Hegdevar Hospital , Garkheda, Aurangabad-431005, India
Approved
Ethics Committee SMS Medical College & Attached Hospital, J.L.N marg, Jaipur rajasthan, 302004
Approved
Ethics Committee, S P Medical College, Bikaner
Approved
Institutional Ethics Committee D Y Patil Medical College
Submittted/Under Review
Institutional Ethics committee, K.G Hospital, K Govindaswami Naidu Medical trust
Approved
Institutional Ethics Committee-Clinical StudiesApollo Speciality Hospital, Lake View road, K K Nagar, Madurai -625020
Approved
LPR Ethics Committee Lifepoint Multispecialty Hospital, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad,Pune-411057,Maharashtra,lndia.
Approved
Manga care Ethics Committee, C/o Chopda Medical & Research Centre Pvt.Ltd, magum Heart Institute, 3/5, patil Lane no 1, Laxmi Nagar, Near K.B.H, Vidyalaya, Canada Corner, nashik, 422005, Maharastra India
Penta-Med Ethics Committee  Medipoint Hospitals Pvt. Ltd  Medipoint Hospitals Pvt.Ltd 241/1, New D.P.Road,  Near Sai Heritage,Aundh Pune Pune Maharashtra -  411007 IndiaÂ
1. Men or women aged 18 to 75 years, inclusive.
2. Patients with acute ischemic stroke as per the pre-treatment CT and NIH stroke scale and
eligible for IV thrombolysis.
3. Patients presenting in the hospital and eligible to receive TenectaseTM as per the
prescribing information.
OR
Patients presenting in the hospital <4.5 hours from the onset of symptoms.
4. Consent from Legally Acceptable Representative (LAR) would be obtained, 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.
5. Patient independent prior to the stroke (estimated modified Rankin Scale 0-1).
ExclusionCriteria
Details
1. Evidence findings on pre-treatment CT that indicate that the patient is unlikely to benefit
from treatment:
A) Infarction comprising more than >1/3 of the middle cerebral artery territory and ASPECTS score of ≤ 7
B)Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g.
cerebral tumour)
2. Hypodense lesion on pre-treatment CT consistent with recent cerebral ischaemia other than the presenting event.
3. Large areas (greater than one lobe) of obvious low density on baseline head CT scan.
4. Rapidly improving or minor acute ischemic stroke symptoms
5. Subjects with Positive COVID antigen test
6. Systolic BP > 180 or diastolic BP > 110 mmHg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP below these limits
7. Clinical history suggestive of subarachnoid haemorrhage even if no blood is evident on
CT scan
8. Active internal bleeding except menstruation
9. Patients with severe hypoglycaemia (blood glucose <50mg/dL) or severe hyperglycaemia
(blood glucose >400 mg/dL) sufficient to account for neurological symptoms
10. Seizure at onset of symptoms unless brain imaging identifies positive evidence of significant brain ischaemia (e.g. Early ischaemic change or hyperdense vessel on plain CT or computerised tomography angiography (CTA) scan confirmed arterial occlusion)
11. Patients taking warfarin and INR > 1.7
12. Patients taking a direct oral anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban)
unless the last dose was taken more than 12 hrs prior to screening and along with normal
coagulation assays
13. Low molecular weight heparins (LMWH) (at doses other than prophylaxis of venous
thromboembolism) administered within the preceding 48 hours, Unfractionated heparin
administered within the previous 48 hours and aPTT is prolonged
14. Significant non-stroke intracranial pathology likely to account for clinical presentation or
represent a risk of intracerebral haemorrhage (e.g.,CNS neoplasm) on pre-treatment CT
15. More than one stroke episode within the previous 14 days prior to screening
16. Thrombolytic therapy within the previous 14 days prior to screening
17. History of Intracranial neoplasm or aneurysm
18. Myocardial infarction within 30 days prior to screening
19. Intracranial or intraspinal surgery or intracranial trauma within past 2 months
20. History of arteriovenous maltransformation
21. Patients with high risk of haemorrhage including history of major surgery or major
trauma within 21 days prior to screening
22. Patient with history of gastrointestinal or urinary tract haemorrhage within 21 days prior
to screening
23. Arterial puncture at a non-compressible site within 7 days prior to screening
24. Prolonged cardiopulmonary resuscitation (>2min) within 14 days prior to screening
25. Current acute pericarditis and/or sub-acute bacterial endocarditis
26. Patients with acute pancreatitis
27. History of severe hepatic dysfunction, including hepatic failure, cirrhosis, portal
hypertension (oesophageal varices) and active hepatitis
28. History of active peptic ulceration
29. Known history of haemorrhagic stroke
30. Patients with known bleeding diathesis and/or platelet count <100 000/mm3.
31. Acute endovascular treatment for stroke is planned.
32. Patients with known history of HIV, HBsAg or HCV.
33. Any major medical condition that is likely to limit survival to Day 90.
34. Pregnancy or lactation, or parturition within the previous 30 days. Women of childbearing
potential must have a negative pregnancy test.
35. Participation in any clinical study of an investigational product within previous 3 months.
36. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease that renders the patient incapable of participating in the study.
37. History of other disease, active systemic infection, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or that might
affect interpretation of the results of the study or render the subject at high risk for
treatment complications.
38. Any other condition which the investigator feels would pose a significant hazard to
patient if tenecteplase is administered.
39. Patient unlikely to complete Day 90 follow-up
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Mean change in the modified Rankin Scale (mRS)
at Day 90
Secondary Outcome
Outcome
TimePoints
Full neurological recovery defined as mRS score of 0-1
at Day 90
Independent recovery defined as mRS score 0-2
at Day 90
Early major neurological improvement from baseline NIHSS total score
at 24 hours
Change from baseline in Health Related Quality of Life
at Day 7, Day 30 and Day 90
Change from baseline in Barthel Index score
at Day 7, Day 30 and Day 90
All-cause Mortality
at Day 90
Incidence of Symptomatic Intra-Cerebral Haemorrhage (SICH)
up to Day 90
Incidence of Parenchymal Haematoma type 2 (PH2) haemorrhage based on European
Cooperative Acute Stroke Study (ECASS) II on post-treatment CT scan
up to 36 hours after study drug administration.
Incidence of intracranial haemorrhage
within 36 hours of study drug administration on
CT scan
Incidence of significant extra-cranial haemorrhage (requirement for blood transfusion or drop in haemoglobin of ≥2.0mg/dL)
within 36 hours of study drug administration
Immunogenicity assessment
at baseline, Day 7, Day 30 and at safety follow up visit (Day 90) or at withdrawal visit
Target Sample Size
Total Sample Size="225" Sample Size from India="225" 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 phase II/III, prospective, multi-center, open label, non-inferiority, two-arm, parallel group, active control, randomized, comparative clinical study to evaluate efficacy, safety and immunogenicity of R-TPR-012 (0.25 mg/kg) with Tenectase (0.20 mg/kg) in patients with acute ischemic stroke.