A comparative clinical study to evaluate efficacy and safety of test drug in patients with Acute Ischemic stroke
Phase 2/3
Recruiting
- Conditions
- Diseases of the nervous system,
- Registration Number
- CTRI/2021/06/034395
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 225
Inclusion Criteria
- Men or women aged 18 to 75 years, inclusive.
- Patients with acute ischemic stroke as per the pre-treatment CT and NIH stroke scale and eligible for IV thrombolysis.
- 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.
- 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.
Exclusion Criteria
- 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.
- Large areas (greater than one lobe) of obvious low density on baseline head CT scan.
- 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.
- Current acute pericarditis and/or sub-acute bacterial endocarditis 26.
- Patients with acute pancreatitis 27.
- Known history of haemorrhagic stroke 30.
- Acute endovascular treatment for stroke is planned.
- Pregnancy or lactation, or parturition within the previous 30 days.
- Participation in any clinical study of an investigational product within previous 3 months.
- 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.
- 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.
- Any other condition which the investigator feels would pose a significant hazard to patient if tenecteplase is administered.
- Patient unlikely to complete Day 90 follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in the modified Rankin Scale (mRS) at Day 90
- Secondary Outcome Measures
Name Time Method 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 Incidence of intracranial haemorrhage within 36 hours of study drug administration on 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
Trial Locations
- Locations (17)
Advance Neurology & Superspeciality hospital
🇮🇳Jaipur, RAJASTHAN, India
All India Institute of Medical Sciences, Bhubaneswar, Odisha
🇮🇳Khordha, ORISSA, India
Apollo Speciality Hospitals
🇮🇳Madurai, TAMIL NADU, India
Asopa Hospital
🇮🇳Jaipur, RAJASTHAN, India
Chopda Medical & Research Centre Pvt.Ltd, magum Heart Institute
🇮🇳Nashik, MAHARASHTRA, India
Dhiraj Hospital, Sumandeep Vidyapeeth
🇮🇳Vadodara, GUJARAT, India
Dr. D.Y Patil Medical College, Hospital & Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Hegdevar Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
KG Hospital & Post Graduate Medical institute & Research
🇮🇳Coimbatore, TAMIL NADU, India
Lifepoint Multispecialty Hospilal
🇮🇳Pune, MAHARASHTRA, India
Scroll for more (7 remaining)Advance Neurology & Superspeciality hospital🇮🇳Jaipur, RAJASTHAN, IndiaDr Sunit ShahPrincipal investigator9252546364advanceneuroresearch@gmail.com