EUCTR2016-002075-10-GB进行中（未招募）1 期
Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis 2 - Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis 2
HS Greater Glasgow & Clyde0 个研究点目标入组 1,870 人开始时间: 2016年9月14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
- 1,870
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
- •1) Eligible for IV thrombolysis.
- •2) Male or non-pregnant female =18 years of age.
- •3) <4.5h after symptom onset.
- •4) Consent of patient or legal representative.
- •5) Independent prior to the stroke (estimated mRS 0-2).
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1300
排除标准
- •1) Contraindications to thrombolytic therapy:
- •(i) Evidence of intracranial haemorrhage or significant non-stroke intracranial pathology likely to account for clinical presentation or represent a risk of intracerebral haemorrhage (eg CNS neoplasm) on pre-treatment CT
- •(ii) Stroke within the previous 14 days, thrombolytic therapy within the past 14 days, or hypodensity on pre-treatment CT consistent with recent cerebral ischaemia other than the presenting event
- •(iii) systolic blood pressure >185 or diastolic BP >110 mm Hg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP to these limits
- •(iv) Clinical history suggestive of subarachnoid haemorrhage even if no blood is evident on CT
- •(v) High risk of haemorrhage, including major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days; Arterial puncture at a non-compressible site within the previous 7 days; Prolonged cardiopulmonary resuscitation (> 2minutes) within the previous 14 days; acute pericarditis and/or subacute bacterial endocarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis; active peptic ulceration; known history of haemorrhagic stroke; Known defect of clotting or platelet function (other than antiplatelet therapy)
- •(vi) Hypo- (< 50 mg/dL or <2.8 mmol/L) or hyperglycaemia (>400 mg/dL or >22.2 mmol/L) sufficient to account for neurological symptoms.
- •(vii) Seizure at onset of symptoms unless brain imaging identifies positive evidence of significant brain ischaemia (eg early ischaemic change or hyperdense vessel on plain CT, CTA confirmed arterial occlusion)
- •(viii) Pregnancy (For women of child-bearing potential a negative pregnancy test will be required prior to randomisation).
- •(ix) Inadequate haemostasis:
- •?- Taking warfarin and INR >1.3.
- •?- Taking a Direct Oral Anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) unless known to be >12 hours since last dose and with normal coagulation assays.
- •?- Low molecular weight heparin (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.
- •2) Any major medical condition likely to limit survival to day 90.
- •3) Unavailable for day 90 follow-up.
研究者
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