EUCTR2005-003176-38-SK进行中（未招募）1 期
A placebo controlled trial of alteplase (rt-PA) in acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4 hours 30 minutes after stroke onset - ECASS III
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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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