EUCTR2018-002195-40-ES进行中（未招募）1 期
CHemical OptImization of Cerebral Embolectomyin patients with acute stroke treated with mechanical thrombectomy
Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 200 人开始时间: 2018年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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.Patients with symptomatic large vessel occlusion (LVO) in the anterior, middle or posterior cerebral arteries treated with MT resulting in a mTICI score 2b at end of the procedure
- •2.Estimated delay to onset of rescue intraarterial rt-PA or placebo administration <24 hours from symptom onset, defined as the point in time the patient was last seen well
- •3.No significant pre-stroke functional disability (modified Rankin scale 0-1)
- •4.Age =18
- •5.ASPECTS >6 on non-contrast CT (NCCT) scan if symptoms lasting <4.5 hours or ASPECTS > 6 on CT-Perfusion (CTP) if symptoms >4.5 <24 hours. In both cases, ASPECTS is obtained within <75 minutes of the onset of mechanical thrombectomy
- •6.Informed consent obtained from patient or acceptable patient surrogate
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1.NIHSS score on admission >25
- •2.Contraindication to IV t-PA as per local national guidelines (except time to therapy)
- •3.Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy
- •4.Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- •5.Current participation in another investigation drug or device treatment study (except observational study i.e.: RACECAT)
- •6.Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- •7.Known coagulopathy, INR >1.7 or use of novel anticoagulants <12h from symptom onset
- •8.Platelets <50,000
- •9.Renal Failure as defined by a serum creatinine >3.0 mg/dl (or 265.2 µmol/l) or glomerular Filtration Rate [GFR] <30
- •10.Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
- •11.Any hemorrhage on CT/MRI
- •12.Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- •13.Suspicion of aortic dissection
- •14.Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
- •15.History of life threatening allergy (more than rash) to contrast medium
- •16.SBP >185 mmHg or DBP >110 mmHg refractory to treatment
- •17.Serious, advanced, terminal illness with anticipated life expectancy <6 months
- •18.Pre-existing neurological or psychiatric disease that would confound evaluation
- •19.Presumed vasculitis or septic embolization
- •20.Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas)
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