CTRI/2021/06/034395招募中2 期
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 Tenectase™ (0.20 mg/kg) in patients with Acute Ischemic stroke
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
- •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
- •5. Patient independent prior to the stroke (estimated modified Rankin Scale 0-1).
排除标准
- •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
- •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
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