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

Ischemic Stroke Clinical Trial

Official title:

A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526225
• Other study ID #: 1412-Z-YXET-ZS-RE
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3452
• Est. completion date: August 31, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 Chinese medical association of the fourth national conference on cerebrovascular disease);

3. The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);

4. The degree of nerve function defect score (NIHSS) score 4 to 24 points, body movement component (NIHSS score paragraphs 5 and 6) total score 2 points or higher;

5. Understand and voluntarily signed informed consent.

Exclusion Criteria:

1. Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, 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 venous thrombosis;

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 of malignant 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 medicine ingredients 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 to participate in this study.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Ginkgo diterpene lactone meglumine injection
5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
• Ginkgo diterpene lactone meglumine injection simulation
5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.

Locations

Country	Name	City	State
China	Tiantan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .		90 days
Secondary	Proportion of patients with National Institutes of Health Stroke Score (NIHSS) rising 4 or more points, three points, two points, one of the subjects changes from baseline to randomized 7 days.		Baseline, 7days
Secondary	Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reducing 4 points or more changes from baseline to randomized 7 days,14 days.		Baseline,7 days,14 days,
Secondary	Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .		90 days
Secondary	The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.		Baseline,14 days,90 days
Secondary	The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.		Baseline,14 days,90 days
Secondary	The all-cause mortality		90 days
Secondary	Ischemic stroke recurrence rate		90 days
Secondary	Composite incidence of vascular events		90 days