ACTRN12613000243718终止3 期
A multicentre, prospective, randomised, open-label, blinded endpoint, controlled phase III non-inferiority trial with an with an adaptive sample size re-estimation in stroke thrombolysis patients to compare tenecteplase and alteplase.
Acute Stroke Service0 个研究点目标入组 680 人开始时间: 2013年2月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 680
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients presenting with acute hemispheric ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset.
- •2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
- •Imaging inclusion criteria:
- •1. Presence of penumbra - Using CTP or perfusion MR mismatch between the Tmax > 6 seconds delay perfusion volume and CTP relative cerebral blood flow (relCBF) or diffusion MR lesion infarct core volume
- •a) Mismatch ratio between Tmax perfusion lesion volume and infarct core lesion volume of > 1.8
- •b) Penumbra volume > 15 mL (Tmax lesion volume –infarct core lesion volume), and
- •2. Infarct core lesion volume < 70 mL. Note minimum slice coverage required for CTP will be 80 mm to prevent underestimation of infarct core volume with this modality.
- •3. Volume of severely hypoperfused tissue < 100mL (Tmax > 10 seconds delay or Delay Time > 8 seconds) indicative of poor response to reperfusion.
排除标准
- •1. Intracranial haemorrhage (ICH) identified on baseline CT or MRI.
- •2. Rapidly improving symptoms at the discretion of the investigator.
- •3. Pre-stroke mRS score of greater than or equal to 2 (indicating previous disability).
- •4. Participation in any investigational study in the previous 30 days.
- •5. Any terminal illness such that patient would not be expected to survive more than one year.
- •6. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
- •7. Pregnant women.
- •8. Previous stroke within last three months.
- •9. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
- •10. Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (INR > 1.5).
- •11. Current use of novel oral anticoagulants (NOACs) (i.e. dabigatran, rivaroxaban, or apixiban).
- •12. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
- •13. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) prior to study entry is permitted.
- •14. Clinically significant hypoglycaemia.
- •15. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or > 110 mmHg diastolic on at least two separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of aggressive treatment” is left to the discretion of the responsible Investigator.
- •16. Hereditary or acquired haemorrhagic diathesis.
- •17. Gastrointestinal or urinary bleeding within the preceding 21 days.
- •18. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
- •19. Exposure to a thrombolytic agent within the previous 72 hours.
- •20. An extracranial or intracranial internal carotid artery occlusion or a proximal M1 middle cerebral artery occlusion which, in the judgment of the investigator, would be more appropriately treated with combined intravenous intra-arterial therapy, where the intra-arterial therapy can be accessed and delivered within a rapid time frame.
- •21. A known hypersensitivity to the active substance alteplase, tenecteplase, gentamicin or to any of the excipients.
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