CTRI/2021/06/034395招募中2/3 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 Tenectaseâ„¢ (0.20 mg/kg) in patients with Acute Ischemic stroke
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 17
- 主要终点
- Mean change in the modified Rankin Scale (mRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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)
- •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
- •Subjects with Positive COVID antigen test
- •Systolic BP > 180 or diastolic BP > 110 mmHg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP below these limits
- •Clinical history suggestive of subarachnoid haemorrhage even if no blood is evident on CT scan
- •Active internal bleeding except menstruation
- •Patients with severe hypoglycaemia (blood glucose <50mg/dL) or severe hyperglycaemia (blood glucose >400 mg/dL) sufficient to account for neurological symptoms
- •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)
- •Patients taking warfarin and INR > 1.7
- •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
- •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
- •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
- •More than one stroke episode within the previous 14 days prior to screening
- •Thrombolytic therapy within the previous 14 days prior to screening
- •History of Intracranial neoplasm or aneurysm
- •Myocardial infarction within 30 days prior to screening
- •Intracranial or intraspinal surgery or intracranial trauma within past 2 months
- •History of arteriovenous maltransformation
- •Patients with high risk of haemorrhage including history of major surgery or major trauma within 21 days prior to screening
- •Patient with history of gastrointestinal or urinary tract haemorrhage within 21 days prior to screening
- •Arterial puncture at a non-compressible site within 7 days prior to screening
- •Current acute pericarditis and/or sub-acute bacterial endocarditis
- •Patients with acute pancreatitis
- •Known history of haemorrhagic stroke
- •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.
结局指标
主要结局
Mean change in the modified Rankin Scale (mRS)
时间窗: at Day 90
次要结局
- 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)
研究者
研究点 (17)
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