NL-OMON49177撤回2 期
Randomized, double blind, mutlicenter, multinational, placebo controlled, single parallel escalating dose safety and efficacy study of ACT017 used as an add-on therapy on top of standard of care of acute ischemic stroke - ACT-CS-002
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1 Patients presenting with an acute disabling ischemic stroke in either the
- •anterior or posterior circulation.The time of onset is known or if unknown, the
- •last time the patient was seen well, was at most 4.5 hrs before confirmation of
- •the diagnosis enabling the initiation of alteplase administration within this
- •time-frame;
- •2. Patients presenting at least a NIHSS * 6 prior to thrombolysis with tPA;
- •3. Patients eligible for, or administered thrombolysis treatment with tPA;
- •4. Patients who can undergo mechanical thrombectomy if eligible;
排除标准
- •1.Coma, and/or NIHSS >25;
- •2.Prior ischemic stroke within the past 3 months with pre-stroke mRS known to
- •3. Baseline CT-scan evaluation: more than 1/3 of the middle cerebral artery)
- •regions of clear hypodensity on the baseline imaging;
- •4. Significant mass effect with midline shift;
- •5. Stroke of hemorrhagic origin;
- •6. Contra-indications to thrombolysis with tPA:
- •7. Patients receiving a dual antiplatelet treatment;
- •8. Cardiopulmonary resuscitation within the past 10 days;
- •9. Epileptic seizure at the onset of symptoms;
- •10. Known severe (grade 3 and above) renal impairment or Glomerular Filtration
- •Rate < 30 ml/min/1.73 m2 or Serum Creatinine > 2X ULN (1.2 mg/dL for men and
- •1.0 mg/dL for women) at screening;
研究者
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