ACTRN12615000220561尚未招募2 期
A randomized controlled trial of the efficacy of intravenous tenecteplase versus alteplase within 4.5 hours of ischemic stroke onset in patients undergoing endovascular therapy, utilizing dual target vessel occlusion and penumbral mismatch imaging selection
euroscience Trials Australia0 个研究点目标入组 64 人开始时间: 2015年3月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
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 ischemic stroke eligible using
- •standard criteria to receive IV thrombolysis within 4.5 hours
- •of stroke onset
- •2. Patient is 18 years or older
- •3. Intra-arterial clot retrieval treatment can commence (groin
- •puncture) within 6 hours of stroke onset.
- •Imaging inclusion criteria
- •Dual target:
- •5. Arterial occlusion on CT angiography of the internal carotid, middle cerebral (M1/M2 segments) or basilar artery
- •6. Mismatch (only applies to anterior circulation)- Using CT perfusion with a Tmax >6 second delay perfusion volume and CT-rCBF ischemic core volume.
- •a) Mismatch ratio of greater than 1.2, and
- •b) Absolute mismatch volume of greater than 10 ml, and.
- •c) Ischemic core lesion volume of less than 70m
排除标准
- •1. Intracranial hemorrhage (ICH) identified by CT
- •2. Rapidly improving symptoms at the discretion of the
- •investigator
- •3. Pre-stroke mRS score of >=4 (indicating previous disability)
- •4. Hypodensity in >1/3 MCA territory or equivalent proportion
- •of basilar artery territory on non-contrast CT
- •5. Contra indication to imaging with contrast agents
- •6. Any terminal illness such that patient would not be expected
- •to survive more than 1 year
- •7. 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.
- •8. Pregnant women
研究者
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