Clinical trial NCT02526225: A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.
Official title: A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke
safety and effectiveness
Ginkgo diterpene lactone meglumine injection
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2015-08-18
Enrollment: 3452
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .
timeFrame: 90 days
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 7days
measure: 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.
timeFrame: Baseline,7 days,14 days,
measure: Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .
timeFrame: 90 days
measure: The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.
timeFrame: Baseline,14 days,90 days
measure: The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.
timeFrame: Baseline,14 days,90 days
measure: The all-cause mortality
timeFrame: 90 days
measure: Ischemic stroke recurrence rate
timeFrame: 90 days
measure: Composite incidence of vascular events
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital,Capital Medical University,Bgeijing,China
name: yongjun wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: