EUCTR2015-002657-36-GB进行中（未招募）1 期
Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial - TASTE
niversity of Newcastle0 个研究点目标入组 1,024 人开始时间: 2015年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,024
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •General Inclusion Criteria:
- •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.
- •3. Patient’s age is = 18 years.
- •Imaging inclusion criteria:
- •1. Vessel occlusion on CT or MR angiography is NOT a requirement for inclusion into the study. However, the presence or absence of ICA occlusion on CT or MR angiography will be required to be noted for randomisation stratification.
- •2. Presence of penumbra - Using CTP or perfusion MR, mismatch between the perfusion lesion measured on Delay Time > 3 seconds and the infarct core lesion measured on CTP relative cerebral blood flow (relCBF) or diffusion MR
- •a) Mismatch ratio between (Delay Time) perfusion lesion and infarct core lesion of > 1.8
- •b) Penumbra volume > 15 mL (Delay Time lesion volume – infarct core lesion volume)
- •3. 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.
- •4. Volume of severely hypoperfused tissue < 100 mL. Severely hypoperfused tissue will be defined by tissue with Delay Time > 8 seconds. Large volumes of severely hypoperfused tissue are indicative of a poor response to treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 224
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 = 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 judgement 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, edoxaban 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.
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