A Phase 2/3 interventional study of Ginkgo diterpene lactone meglumine injection and Ginkgo diterpene lactone meglumine injection simulation in Ischemic Stroke, Acute, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Phase 2/3, Interventional, and Treatment
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
This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 80 patients (age > 40 years) with acute ischemic stroke (5\<NIHSS \< 25), who can be treated within 4.5 to 48 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive a Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14（the injection must be added slowly into 0.9% sodium chloride injection diluted to 250 ml , intravenous drip for about 2 hours）, combined with Acetylsalicylic acid (Aspirin) at a dose of 100 mg/d for 90 days;2) the other group will receive the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.The primary objective is to assess the anti-platelet effects of Ginkgo Diterpene Lactone Meglumine Injection combined with Aspirin versus Aspirin alone in patients with acute ischemic stroke. The study consists of 3 visits including the day of randomization, Day 14±2days and Day 90±7days.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.A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 35 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days.
Drug: Ginkgo diterpene lactone meglumine injection · Drug: Aspirin
Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days.
Drug: Ginkgo diterpene lactone meglumine injection simulation · Drug: Aspirin
Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
Also known as: YinxingErtieneizhiPu'an Zhusheye
Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
Also known as: YinxingErtieneizhiPu'an Zhusheye simulation
plus aspirin at a dose of 100 mg per day for 90 days.
Also known as: Acetylsalicylic acid
Proportion of patients with Modified Rankin Scale (mRS)
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 . The mRS scores range from 0 to 6, ranging from perfect health without symptoms to death
Time frame: 90 days
New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)
All the new vascular events will be assessed by at least two neurologists based on neuroimaging and clinical feature. When there was disagreement, a third senior neurologist was consulted to reach a consensus decision.
Time frame: 90 days
Plan to share: No
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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Yueyang Integrated Medicine Hospital