EUCTR2005-003176-38-CZ进行中（未招募）不适用
A placebo controlled trial of alteplase (rt-PA) in acute ischemichemispheric stroke where thrombolysis is initiated between 3 and 4hours 30 minutes after stroke onset - ECASS III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •Female or male inpatients
- •Age: 18 - 80 years.
- •Clinical diagnosis of ischemic stroke causing a measurable neurological deficit
- •defined as impairment of language, motor function, cognition and/or gaze,
- •vision or neglect. Ischemic stroke is defined as an event characterized by the
- •sudden onset of an acute focal neurologic deficit presumed to be due to
- •cerebral ischemia after CT scan excludes hemorrhage.
- •Onset of symptoms between 3 and 4 hours 30 minutes prior to initiation of administration
- •of study drug.
- •Stroke symptoms are to be present for at least 30 minutes and have not
- •significantly improved before treatment. Symptoms must be distinguishablefrom an episode of generalized ischemia (i.e. syncope), seizure, or migraine
- •Patient is willing to participate voluntarily and to sign a written patient
- •informed consent. Informed consent will be obtained from each patient or the
- •subject’s legally authorized representative or relatives, or defered where
- •applicable, according to the regulatory and legal requirements of the
- •participating country.
- •Patients who are unable to sign but who are able to understand the meaning of
- •participation in the study may give an oral witnessed informed consent. These
- •patients have to make clear undoubtfully that they are willing to participate
- •voluntarily and must be able to understand an explanation of the contents of the
- •information sheet.
- •Willingness and ability to comply with the protocol.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of intracranial hemorrhage (ICH) on the CT-scan.
- •Symptoms of ischaemic attack began more than 4 hours 30 minutes prior to infusion start or when time of symptom onset is unknown.
- •Minor neurological deficit or symptoms rapidly improving before start of
- •Severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate
- •imaging techniques.
- •Epileptic seizure at onset of stroke
- •Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is
- •Administration of heparin within the previous 48 hours and a thromboplastin
- •time exceeding the upper limit of normal for laboratory
- •Patients with any history of prior stroke and concomitant diabetes
- •Prior stroke within the last 3 months
- •Platelet count of below 100,000/mm3.
- •Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits.
- •Blood glucose < 2.77 or > 22.15 mmol / l.
- •Known haemorraghic diathesis
- •Patients receiving oral anticoagulants, e.g. warfarin sodium
- •Manifest or recent severe or dangerous bleeding
- •Known history of or suspected intracranial haemorrhage
- •Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
- •Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial
- •or spinal surgery)
- •Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate
- •haemorrhagic retinopathy)
- •Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture.
- •Known bacterial endocarditis, pericarditis.
- •Acute pancreatitis
- •Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation
- •Neoplasm with increased bleeding risk
- •Severe liver disease, including hepatic failure, cirrhosis, portal hypertension
- •oesaphageal varices) and active hepatitis
- •Major surgery or significant trauma in past 3 months.
- •Current or recent (within 3 months) participation in another investigational drug treatment protocol.
研究者
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