跳至主要内容
临床试验/ITMCTR2100004970
ITMCTR2100004970尚未招募4 期

A Randomized, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Xingnaojing for Acute Ischemic Stroke patients with Endovascular Thrombectomy

Beijing Tiantan Hospital, Capital Medical University0 个研究点开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

性别
Male

入选标准

  • 1. Patients over 18 years old;
  • 2. Acute ischemic stroke was diagnosed
  • 3. MRA or CTA showed occlusion of anterior circulation arteries
  • 4. Acute intravascular therapy (including simple intravascular therapy and bridging therapy) within 24 hours of onset
  • 5. Randomization was completed within 24 hours after operation
  • 6. ICF should be signed by patients or family members

排除标准

  • 1.Treated with Xingnaojing injection
  • 2. Patients with transient ischemic attack
  • 3. Patients with cerebral hemorrhage on imaging examination
  • 4. Patients with vasculitis
  • 5. ALTAST = 3 times of the upper limit of normal value, Cr = 2 times of the upper limit of normal value
  • 6. Patients with a tendency of bleeding, and severe bleeding occurred within 3 months
  • 7. Allergic to Xingnaojing, ethanol, glycerin or allergic constitution
  • 8. Patients with pregnancy planning, pregnancy or lactation
  • 9. Patients with severe heart, liver, kidney disease or malignant tumor, life expectancy < 3 months
  • 10. Patients participating in other drug clinical studies
  • 11. The patients who are not suitable for the clinical study (such as those with mental and mental disorders, etc.) are considered by the researchers.

研究者

相似试验

进行中(未招募)
1 期
This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With EculizumabParoxysmal Nocturnal HemoglobinuriaMedDRA version: 21.1Level: LLTClassification code 10055629Term: Paroxysmal nocturnal hemoglobinuriaSystem Organ Class: 100000004857
EUCTR2017-002370-39-SEAlexion Pharmaceuticals, Inc.136
进行中(未招募)
1 期
This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab
EUCTR2017-002370-39-ESAlexion Pharmaceuticals, Inc.105
进行中(未招募)
1 期
This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With EculizumabParoxysmal Nocturnal HemoglobinuriaMedDRA version: 21.1Level: LLTClassification code 10055629Term: Paroxysmal nocturnal hemoglobinuriaSystem Organ Class: 100000004857
EUCTR2017-002370-39-FIAlexion Pharmaceuticals, Inc.136
进行中(未招募)
1 期
This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With EculizumabParoxysmal Nocturnal HemoglobinuriaMedDRA version: 20.1Level: LLTClassification code 10055629Term: Paroxysmal nocturnal hemoglobinuriaSystem Organ Class: 100000004857
EUCTR2017-002370-39-CZAlexion Pharmaceuticals, Inc.136
进行中(未招募)
1 期
This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With EculizumabParoxysmal Nocturnal HemoglobinuriaMedDRA version: 21.1Level: LLTClassification code 10055629Term: Paroxysmal nocturnal hemoglobinuriaSystem Organ Class: 100000004857
EUCTR2017-002370-39-BEAlexion Pharmaceuticals, Inc.136