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

Phase 2

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Ginkgo diterpene lactone meglumine injection simulation; Drug: Ginkgo diterpene lactone meglumine injection

• Registration Number: NCT02526225
• Lead Sponsor: Beijing Tiantan Hospital

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

Study Timeline

• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Study Start: 2016-02-01
• Primary Completion: 2018-05-01
• Study Completion: 2019-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3452

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginkgo diterpene lactone meglumine injection simulation	Ginkgo diterpene lactone meglumine injection simulation	Ginkgo diterpene lactone meglumine injection simulation
ginkgo diterpene lactone meglumine injection	Ginkgo diterpene lactone meglumine injection	ginkgo diterpene lactone meglumine injection

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .	90 days

Secondary Outcome Measures

Name	Time	Method
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
Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .	90 days
Ischemic stroke recurrence rate	90 days
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,
The all-cause mortality	90 days
The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.	Baseline,14 days,90 days
The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.	Baseline,14 days,90 days
Composite incidence of vascular events	90 days

Trial Locations

Locations (1)

Tiantan Hospital; 🇨🇳 Beijing, Beijing, China