EUCTR2009-012086-66-SK进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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: a) within 8.5 hours of stroke onset in cohorts 1, 2a and 2b; b) within 8 hours of stroke onset in cohort 2c; and c) 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient is eligible for IV administration of tissue plasminogen activator (e.g.
- •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 the study
- •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
- •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 products
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