EUCTR2009-012086-66-DE进行中（未招募）不适用
A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Grifols Inc
- 入组人数
- 61
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. 18 through 85 years of age, inclusive
- •2. Male and female patients
- •3. New focal, potentially disabling neurologic deficit clinically localized to the MCA distribution
- •4. Catheter Arteriography - Complete occlusion or contrast penetration with minimal perfusion of either the M1 segment and/or M2 segment and/or M2 division of the MCA (M1, M2, or M1-2 only) as assessed by arteriography (Section 3.2.3.1)
- •5. Intra-arterial (IA) therapy with Plasmin must be completed within 9 hours of stroke onset (e.g., Plasmin
- •infusion must start: 1) within 8.5 hours of stroke onset in cohorts 1, 2a and 2b; 2) within 8 hours of stroke onset in cohort 2c; and 3) within 8 or 8.5 hours of stroke onset in cohort 3, depending on the infusion rate/time selected from cohort 2).
- •6. An NIHSS score of =4 and =25, except for isolated aphasia
- •7. Women of child-bearing potential must practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception,
- •placement of an intrauterine device [IUD] or intrauterine system [IUS], condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study and must have a negative pregnancy test prior to study entry
- •8. Willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the patient in accordance with local law and institutional policy
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •1. Patient is eligible for IV administration of tissue plasminogen activator (e.g. alteplase)
- •2. Previous treatment for this event with mechanical embolectomy or cerebral angioplasty / stenting of target lesion
- •3. Treatment with any PA (e.g., streptokinase (e.g., Streptase®, Kabikinase®), anistreplase (Eminase®), alteplase (e.g., Activase®), reteplase (e.g., Retavase®), tenecteplase (TNKase™), UK (Abbokinase)) within the last 48 hours
- •4. Therapy with a Glycoprotein IIb/IIIa inhibitor (e.g. abciximab) in the 5 days prior to study enrollment or at any time during the study
- •5. Clinical evidence of significant medical, neurologic, or psychiatric disease that may confound the study outcome assessments
- •6. Women who are pregnant or lactating or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable or implanted
- •hormonal methods of contraception, placement of an intrauterine device [IUD] or intrauterine system [IUS] condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout
- •7. Participation in another treatment clinical study within 30 days prior to entry
- •8. History of intracranial procedures or intracranial or systemic bleeding within the last year
- •9. Previous history of intracranial neoplasm (except meningioma)
- •10. History of stroke in previous 6 weeks
- •11. Within 48 hours, major or minor surgery, biopsy of a parenchymal organ, or major trauma/injury with internal injuries, lumbar puncture or hemorrhage
- •12. Catheter Arteriography - Inability for whatever reason (e.g. arterial stenosis, vessel tortuosity) to access the target lesion and achieve contact between the microcatheter and the proximal aspect of the target thrombus
- •13. Acute ICH of any degree or location
- •14. Evidence of active bleeding/ hemorrhage or acute trauma on physical examination
- •15. Coma or severe obtundation with fixed eye deviation and complete hemiplegia. Coma is defined as 2 or more points in the NIHSS Level of Consciousness exam item.
- •16. An NIHSS score > 25
- •17. Significant intracranial mass effect leading to midline shift
- •18. Acute hypodense/hyperintense parenchymal lesion or effacement of cerebral sulci in more than one third of the MCA distribution as confirmed during pre-study imaging
- •19. Seizures at onset of stroke symptoms
- •20. Uncontrolled hypertension defined by a systolic blood pressure > 180 mmHg or
- •diastolic blood pressure > 110 mmHg on 3 separate occasions at least 10 minutes
- •apart or requiring intravenous antihypertensive treatment by continuous infusion to
- •reduce blood pressure to within these limits
- •21. Known hereditary or acquired hemorrhagic diathesis with baseline international
- •normalized ratio (INR) > 1.7, activated partial thromboplastin time (aPTT) > 1.5
- •times normal, or baseline platelet count <100 x 109/L
- •22. Presence of an unsecured aneurysm
- •23. Clinical presentation suggestive of subarachnoid hemorrhage, even if initial imaging study is normal
- •24. Suspected lacunar stroke
- •25. Proximal stenosis with complete occlusion or simultaneous stenting / angioplasty, if deemed necessary by the interventionalist. Stenosis that does not impair accessibility to the primary lesion is allowed.
- •26. Known or presumed septic embolus
- •27. Creatinine = 2.0 mg/dL or patient on renal dialysis
- •28. Previous severe or anaphylactic or anaphylactoid reaction to contrast agent,
- •streptokinase, or blood product
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