EUCTR2011-005906-32-DE进行中（未招募）1 期
Efficacy and safety of MRI-based thrombolysis in wake-upstroke: a randomised, double-blind, placebo-controlled trial - WAKE-UP
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 800 人开始时间: 2012年5月2日最近更新:
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
- 800
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 Inclusion Criteria
- •- Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g., stroke symptoms recognized on
- •- Last known well (without neurological symptoms) >4.5 hours of treatment initiation
- •- Measurable disabling neurological deficit (defined as an impairment of one or more of the following: language, motor
- •function, cognition, gaze, vision, neglect)
- •- Age 18-80 years
- •-Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening)
- •- Written informed consent by patient or proxy
- •Imaging Inclusion Criteria:
- •- Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR)
- •completed and showing a pattern of DWI-FLAIR-mismatch”, i.e. acute ischemic lesion visibly on DWI (positive
- •DWI”) but no marked parenchymal hyperintensity visible on FLAIR (negative FLAIR”) indicative of an acute ischemic
- •lesion =4.5 hours of age
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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 60
排除标准
- •Clinical Exclusion Criteria
- •- Planned or anticipated treatment with endovascular reperfusion strategies (e.g. intra-arterial thrombolysis,
- •mechanical recanalization techniques)
- •- Pre-stroke disability (inability to carry out all daily activities, requiring some help or supervision, i.e. slight disability
- •corresponding to an MRS score >1)
- •- Participation in any investigational study in the previous 30 days
- •- Severe stroke by clinical assessment (e.g. NIHSS >25)
- •- Hypersensitivity to Alteplase or any of the excipients
- •- Pregnancy or lactating (formal testing needed in woman of childbearing potential; childbearing potential is assumed
- •in women up to 55 years of age)
- •- Significant bleeding disorder at present or within past 6 months
- •- Known haemorrhagic diathesis
- •- Manifest or recent severe or dangerous bleeding
- •- Known history of or suspected intracranial haemorrhage
- •- Suspected subarachnoid haemorrhage (even if CT is negative) or condition after subarachnoid haemorrhage from
- •- History of CNS damage (e.g. neoplasm, aneurysm, intracranial or spinal surgery)
- •- Recent (within 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a
- •non-compressible blood-vessel
- •-Current effective use of anticoagulants (e.g. Phenprocoumon, Warfarin, or new direct oral anticoagulants such as Apixaban, Dabigatran or Rivaroxaban) or current use of heparin and elevated thromboplastin time (low-dose subcutaneous heparin is allowed); inclusion may be considered in patients using vitamin K-antagonists (Phenprocoumon or Warfarin) when appropriate tests of anticoagulant activity (INR) show no clinically relevant activity
- •- Platelet count <100.000/mm3 (<100G/l)
- •- Blood glucose <50 or >400 mg/dl (<2.8 or 22.2 mmol/l)
- •- Severe uncontrolled hypertension, i.e. systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg
- •or requiring aggressive medication to maintain blood pressure within these limits (routine medical treatment is allowed to lower the blood pressure below these limits)
- •- Manifest or recent bacterial endocarditis, pericarditis
- •- Manifest or recent acute pancreatitis
- •- Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial aneurysm, arterial/venous malformations
- •- Neoplasm with increased bleeding risk
- •- Manifest severe liver disease including hepatic failure, cirrhosis, portal hypertension and active hepatitis
- •- Major surgery or significant trauma in past 3 months
- •- Stroke within 30 days
- •- Life expectancy 6 months or less by judgement of the investigator
- •- Any condition associated with a significantly increased risk of severe bleeding not mentioned above
- •- Any contraindication to MRI (e.g. cardiac pacemaker)
- •Imaging Exclusion Criteria:
- •- Poor MRI quality precluding interpretation according to the study protocol
- •- Any sign of intracranial haemorrhage on baseline MRI
- •- FLAIR showing a marked parenchymal hyperintensity in a region corresponding to the acute DWI lesion inidicative of
- •an acute ischemic lesion with a high likelihood of being > 4.5 hours old
- •- Large DWI lesion volume > 1/3 of the MCA or >50% of the anterior cerebral artery (ACA) or posterior cerebral artery (PCA) territory (visual inspection) or >100 ml
- •- Any MRI findings indicative of a high risk of symptomatic intracranial haemorrhage related to potential IV-tPA treatment in the judgement of the investigator
研究者
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