Health Condition 1: G00-G99- Diseases of the nervous system
Conditions
Interventions
Intervention1: Tenecteplase/R-TPR-012 (0.25 mg/kg): R-TPR-012 will be administered at a dose of 0.25mg/kg - maximum 25 mg as a single intravenous bolus over approximately 10
seconds at Day 1.
Control
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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. 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).
Exclusion criteria
Exclusion criteria: 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 (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 <1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the modified Rankin Scale (mRS)Timepoint: at Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Full neurological recovery defined as mRS score of 0-1Timepoint: at Day 90;Independent recovery defined as mRS score 0-2Timepoint: at Day 90;Early major neurological improvement from baseline NIHSS total scoreTimepoint: at 24 hours;Change from baseline in Health Related Quality of LifeTimepoint: at Day 7, Day 30 and Day 90;Change from baseline in Barthel Index scoreTimepoint: at Day 7, Day 30 and Day 90;All-cause MortalityTimepoint: at Day 90;Incidence of Symptomatic Intra-Cerebral Haemorrhage (SICH)Timepoint: 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 scanTimepoint: up to 36 hours after study drug administration.;Incidence of intracranial haemorrhageTimepoint: 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)Timepoint: within 36 hours of study drug administration;Immunogenicity assessmentTimepoint: at baseline, Day 7, Day 30 and at safety follow up visit (Day 90) or at withdrawal visit | — |
Countries
India
Contacts
Public ContactGanesh Bagul
Reliance Life Sciences Pvt. Ltd. (RLS)
Outcome results
None listed