EUCTR2009-012086-66-FR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
- 40
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 Angiography - 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 angiography (Section 3.2.3.1)
- •5.Intra-arterial (IA) therapy can be initiated within 8.5 hours of the last known well time
- •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 a legal 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.Clinical evidence of significant medical, neurologic, or psychiatric disease that may confound the study outcome assessments
- •2.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
- •3.Participation in another treatment clinical study within 30 days prior to entry
- •4.History of intracranial procedures or intracranial or systemic bleeding within the last year
- •5.Previous history of intracranial neoplasm (except meningioma)
- •6.History of stroke in previous 6 weeks
- •7.Within 48 hours, major or minor surgery, biopsy of a parenchymal organ, or major trauma/injury with internal injuries, lumbar puncture or hemorrhage
- •8.Catheter Angiography - Inability for whatever reason (e.g. arterial stenosis, vessel tortuosity) to access the target thrombus and achieve intra-thrombus placement of the microcatheter
- •9.Acute ICH of any degree or location
- •10.Evidence of active bleeding/hemorrhage or acute trauma on physical examination
- •11.Coma or severe obtundation with fixed eye deviation and complete hemiplegia
- •12.An NIHSS score > 25
- •13.Significant intracranial mass effect leading to midline shift
- •14.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
- •15.Seizures at onset of stroke symptoms
- •16.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
- •17.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
- •18.Presence of an unsecured aneurysm
- •19.Clinical presentation suggestive of subarachnoid hemorrhage, even if initial imaging study is normal
- •20.Suspected lacunar stroke
- •21.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.
- •22.Known or presumed septic embolus
- •23.Creatinine = 2.0 mg/dL or patient on renal dialysis
- •24.Previous severe or anaphylactic or anaphylactoid reaction to contrast agent, streptokinase, or blood products
- •25.Patient is eligible for IV administration of tissue plasminogen activator (e.g. alteplase)
- •26.Previous treatment for this event with mechanical embolectomy or cerebral angioplasty / stenting of target lesion
- •27.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
- •28.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
- •29.Previous treatment with systemic heparin within the previous 48 hours.
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