EUCTR2005-004681-16-CZ进行中（未招募）1 期
ASP I (Ancrod Stroke Program)Study of Acute Viprinex™ for Emergency Stroke:A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod (Viprinex™) in Subjects Beginning Treatment within 6 Hours of the Onset of Acute Ischemic Stroke
eurobiological Technologies Inc0 个研究点目标入组 650 人开始时间: 2006年4月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
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. Sudden onset of an ischemia-related neurologic deficit involving the carotid, vertebrobasilar, or cerebral artery territories within 6 hours prior to screening, with symptoms persisting for = 30 minutes
- •Subjects that awaken with stroke symptoms can be enrolled if they were without symptoms within the 6-hour window.
- •2. Clinical diagnosis of acute ischemic stroke based on a general physical examination, neurologic examination, and neuroimaging findings
- •3. Stroke symptoms occurring at a time that would allow initiation of study treatment within 6 hours of recognized onset
- •Subjects will not be excluded based on CT evidence of the index ischemic stroke, but Investigators should be fully satisfied that they have determined the time of symptom onset if there is extensive change related to the index stroke.
- •4. No conditions other than stroke to which the subject's sudden clinical deterioration could have been attributed (e.g., pneumonia or systemic febrile infection), or that might interfere with the neurologic evaluation (e.g., demyelinating disease, superimposed encephalopathy, or multi-infarct dementia)
- •5. Age = 18 years
- •6. Men or women
- •Women must not be pregnant or lactating, and women of childbearing
- •potential must have a negative pregnancy test before receiving study drug.
- •7. Screening NIHSS score of = 5
- •8. mRS score of 0 or 1 prior to onset of index event
- •9. Written consent by the subject (or his/her representative if the subject is unable
- •to sign personally) obtained and noted in the subject's chart
- •Subjects who have signed an Informed Consent Form for any other acute study at the time of the index stroke, including studies involving the use of devices, may not be enrolled in this study.
- •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
- •1. Neuroimaging evidence of intracranial extravascular blood (e.g., cerebral hemorrhage, hemorrhagic infarction, subdural hematoma) or potentially progressive intracranial lesion (e.g., neoplasm or abscess) based on a CT scan of the head
- •2. Stroke known or strongly suspected to be caused by an arterial dissection
- •3. Unconscious or comatose state, that is, a score of > 2 on Item 1a of the NIHSS
- •(level of consciousness)
- •4. Seizures at onset of the stroke
- •5. Prior stroke, ischemic or hemorrhagic, within the previous 6 weeks
- •6. Improvement in the clinical deficit to an NIHSS score of < 5 after randomization
- •and before initiation of study drug
- •7. Note: This criterion has been deleted.
- •8. Anticipated surgery (including angioplasty) or general anesthesia
- •9. Recent (= 24 hours prior to screening) or anticipated arterial puncture at a noncompressible site
- •10. Current stroke occurring = 14 days after major surgery or = 30 days after carotid endarterectomy.
- •11. Last pretreatment systolic blood pressure of > 185 mmHg or diastolic blood
- •pressure of > 105 mmHg, or history of hypertension that is uncontrolled or accompanied by serious complications (e.g., hypertensive encephalopathy)
- •12. Last pretreatment systolic blood pressure of < 90 mmHg
- •13. Heart rate of < 40 beats/min at any time between stroke onset and treatment
- •14. Screening plasma fibrinogen level of < 100 mg/dL
- •If study drug infusion is initiated before the fibrinogen value has been reported, the infusion should be stopped as soon as the investigative staff is notified that the subject’s fibrinogen level is < 100 mg/dL.
- •15. Known disorder of platelet function or coagulation abnormality, use of anticoagulants, such as warfarin, heparin, low–molecular weight heparin, heparinoids, or abciximab (or similar antiplatelet agents), within 72 hours prior to screening, or planned use of an anticoagulant within 72 hours after initiation of study drug
- •Subjects who received warfarin or heparin but who are believed to be inadequately anticoagulated may be treated at the discretion of the Investigator.
- •16. Use of a thrombolytic agent (e.g., rt-PA, urokinase, or streptokinase) within 72 hours prior to screening or planned use of a thrombolytic agent within 5 days after initiation of study drug
- •17. Platelet count of < 100,000/mm3 or hematocrit of < 30%
- •18. Major hemostatic deficit as a result of other illness (e.g., uremia)
- •19. Note: This criterion has been deleted.
- •20. Any of the following clinically significant conditions:
- •Hepatic failure (e.g., alanine aminotransferase [AST] or alanine aminotransferase
- •[ALT] > 3 × upper limit of normal [ULN])
- •Renal failure (e.g., blood urea nitrogen [BUN] or creatinine > 2 × ULN)
- •Respiratory failure (e.g., respirator dependence)
- •Pericarditis, cardiogenic shock, or clinically significant congestive heart
- •Psychiatric disturbance (e.g., depression, schizophrenia, or organic brain
- •Any other disease (e.g., advanced multiple sclerosis or dementia) likely to
- •interfere with the neurologic assessment
- •21. Gastrointestinal or genitourinary bleeding within 30 days prior to screening
- •22. History of chronic alcohol abuse, alcohol abuse within 90 days prior to screening, or history of illicit drug use
- •23. Known or suspected vasculitis
- •24. Blood glucose of < 50 mg/dL
- •25. Prior treatment with ancrod
- •26. Use of another investigational drug within 30 days prior to stroke onset
- •27. Enrollment in another acute interventional s
研究者
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