EUCTR2010-024541-67-GB进行中（未招募）1 期
Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis – pilot phase - Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis
HS Greater Glasgow & Clyde R&D Office0 个研究点目标入组 104 人开始时间: 2011年9月28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
- 104
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
- •Clinical diagnosis of supratentorial acute ischaemic stroke
- •Male or non-pregnant female =18 years of age
- •Within 4.5 hours of onset as defined by time since last known well
- •CTP and CTA examinations acquired prior 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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •Contraindications to thrombolytic drug treatment for stroke
- •oEvidence of intracranial haemorrhage or significant non-stroke intracranial pathology on pre-treatment CT
- •oEstablished hypodensity on pre-treatment brain CT of more than one third of the MCA territory or ASPECT score <4 (sulcal effacement or loss of grey-white differentiation in cortical territories alone are not counted towards ASPECT score)
- •oHypodensity consistent with recent cerebral ischaemia other than the presenting event
- •oIf on warfarin, INR <1.4
- •oSignificant abnormality of coagulation parameters pre-treatment (prolonged INR or APTT, or low platelet count<100x109/l)
- •oClinical history suggestive of SAH even if no blood is evident on CT
- •oMajor surgery within previous 1 month
- •oDependent (mRS 3-5) pre-stroke
- •oBlood glucose <2mmol/l or >22mmol/l
- •Known impaired renal function (eGFR <30ml/min) precluding contrast CT
- •Known allergy to radiological contrast
- •Severe concurrent medical condition that would prevent participation in study procedures (e.g. cardiac failure with severe pulmonary oedema) or with life expectancy = 3 months.
研究者
相似试验
进行中（未招募）
1 期
ATTEST 2: A trial comparing the new clot busting drug treatment tenecteplase with standard clot busting treatmentAcute ischaemic strokeMedDRA version: 21.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-002075-10-GBHS Greater Glasgow & Clyde1,870
已完成
2 期
Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST)StrokeNCT01472926NHS Greater Glasgow and Clyde104
进行中（未招募）
1 期
Evaluation of Tenecteplase versus Alteplase for Stroke Thrombolysis (TASTE) TrialAcute Ischaemic StrokeMedDRA version: 20.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852MedDRA version: 20.1 Level: LLT Classification code 10060848 Term: Ischemic cerebral infarction System Organ Class: 100000004852EUCTR2015-002657-36-FIniversity of Newcastle1,024
进行中（未招募）
1 期
Evaluation of Tenecteplase versus Alteplase for Stroke Thrombolysis (TASTE) TrialAcute Ischaemic StrokeMedDRA version: 22.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersEUCTR2015-002657-36-GBniversity of Newcastle1,024
进行中（未招募）
1 期
Evaluation of Tenecteplase versus Alteplase for Stroke Thrombolysis (TASTE) TrialAcute Ischaemic StrokeMedDRA version: 20.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersEUCTR2015-002657-36-BEniversity of Newcastle1,024