A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.

Last updated: March 28, 2023
Sponsor: Beijing Tiantan Hospital
Overall Status: Completed

Phase

2

Condition

Thrombosis

Stroke

Blood Clots

Treatment

N/A

Clinical Study ID

NCT02526225
1412-Z-YXET-ZS-RE
  • Ages 18-80
  • All Genders

Study Summary

The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 to 80 years of age, and gender not limited。
  2. Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinesemedical association of the fourth national conference on cerebrovascular disease);
  3. The first onset, or always not obvious legacy of stroke sequela (mRS acuities werebefore the onset of 1);
  4. The degree of nerve function defect score (NIHSS) score 4 to 24 points, body movementcomponent (NIHSS score paragraphs 5 and 6) total score 2 points or higher;
  5. Understand and voluntarily signed informed consent.

Exclusion

Exclusion Criteria:

  1. Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess andcause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction,epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoidhemorrhage, etc.
  2. The serious disturbance of consciousness (Ia NIHSS score 2 points or higher);
  3. With hemorrhagic disease or have a bleeding tendency, or have a lower limb venousthrombosis;
  4. Serious abnormal liver and kidney function, liver function laboratory indexes of ALT > 3 ULN, renal laboratory ULN Cr > 1.5);
  5. A history of mental illness or dementia patients;
  6. Severe organ or other systemic disease, accompanied by any organ or system ofmalignant tumor, or ongoing anti-tumor treatment, the estimated lifetime < 3 months;
  7. Significant drug or alcohol abuse;
  8. Allergic constitution, as well as to two or more drugs or food allergies;This medicineingredients allergy or known;
  9. Have pregnancy (check blood HCG positive screening tests, namely HCG > 5 miu/mL),during the test preparation is pregnancy or lactation in women;
  10. In the past three months in other clinical trials;
  11. Researchers do not determine poor adherence, or any other suitable for patients toparticipate in this study.

Study Design

Total Participants: 3452
Study Start date:
February 01, 2016
Estimated Completion Date:
August 31, 2019

Study Description

After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Connect with a study center

  • Tiantan Hospital

    Beijing, Beijing 100050
    China

    Site Not Available

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