JPRN-jRCT2080223556已完成1 期
A phase 1, single blind, placebo-controlled, randomized study to assess the safety of DS-1040b in subjects with thombectomy-treated acute ischemic stroke.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
The objective of this study was to confirm the safety and tolerability of DS-1040b in patients with acute ischemic stroke in whom a thrombectomy device was indicated. There were no subjects who had symptomatic ICH and non-intracranial (TIMI) major bleeding. DS-1040b was safe and well tolerated with an overall safety profile similar to placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 89age old（—）
- 性别
- All
入选标准
- •1. Female and male from 20 to 89 years old
- •2. Acute ischemic stroke patients with CTA or MRA evidence of intracranial vascular occlusion (ICA, MCA M1 division)
- •3. In principle within 8 hours of symptom onset
- •4. Treatment with stent retriever is planned
- •5. NIHSS >= 6, ASPECTS >= 6
排除标准
- •1. Treated with fibrinolysis or fibrinolysis is planned
- •2. Intracranial hemorrhage or subarachnoid hemorrhage is identified by CT or MRI
- •3. Subjects have active bleeding like gastrointestinal hemorrhage
- •4. Subjects with cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
- •5. Subjects with aortic dissection
- •6. Subjects have had head trauma, spinal cord trauma, or intracranial surgery within 3 months
- •7. Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days
- •8. Subjects have had major surgery within 14 days or trauma
- •9. Subjects with an elevated APTT or PTT more than twice of normal range
- •10. INR > 1.7
- •11. Platelet < 100,000/mm3
- •12. Uncontrolled hypertension (SBP > 185 mmHg, DBP > 110 mmHg)
- •13. Blood glucose > 400 mg/dL
- •14. Subjects with more than two major artery occluded
- •15. Inadequate for treatment with stent retrievers, for example, carotid dissection, totally occluded carotid artery, or allergy for contrast agent
- •16. Severe hepatic impairment (fulminant hepatitis, cirrhosis, hepatophyma, TB >= 3.0 mg/dL, AST >= 2.5x ULN, ALT >= 2.5x ULN, ALP >= 2.5x ULN)
- •17. Severe renal impairment patients with chronic dialysis, nephrotic syndrome, acute renal failure, chronic renal failure, uremia, hydronephrosis, or serum creatinine >= 2.0 mg/dL
- •18. History of ischemic stroke within 30 days prior to treatment
- •19. Participant in other clinical trial within 30 days prior to treatment
- •20. Subject with pregnant, during lactation, planning on becoming pregnant during treatment period
- •21. Any other reason, in the opinion of the Investigator, which precludes subjects participation in the study
研究者
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