A comparative clinical study to evaluate efficacy and safety of test drug in patients with Acute Ischemic stroke
- Conditions
- Health Condition 1: G00-G99- Diseases of the nervous system
- Registration Number
- CTRI/2021/06/034395
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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).
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 <1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in the modified Rankin Scale (mRS)Timepoint: at Day 90
- Secondary Outcome Measures
Name Time Method