Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ginkgo Diterpene Lactone Meglumine Injection
Acetylsalicylic acid
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of AIS within 4.5-48 h of symptom onset;
- Aged 40 to 80 years of age, and gender not limited;
- A score of 5-24 points on the National Institute of Health Stroke Scale (NIHSS);
- Written informed consent was available before enrolment.
Exclusion Criteria:
- Cardiogenic cerebral embolism;
- AIS caused by other definite causes (e.g., arterial dissection, vasculitis, vascular malformation, etc.) or undetermined etiology;
- Treated with thrombolysis or intravascular therapy, or with arteriovenous bridging after onset;
- Under dual antiplatelet therapy or anticoagulant therapy;
- A score of more than 2 on the modified Rankin Scale (mRS) (scores range from 0 [no symptoms] to 6 [death]) before the occurrence of AIS;
- Allergy or contraindication to GDLI or aspirin;
- Patients with active bleeding or bleeding tendency, malignancies, severe liver (the serum level of AST and/or ALT > 2 times the upper limit of normal), or renal failure (the serum level of creatinine > 1.5 times the upper limit of normal or GFR < 40 ml/min/1.73m2);
- Anticipated requirement for long-term nonstudy antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function;
- Severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months;
- Planned surgery or interventional treatment requiring cessation of the study drug;
- Pregnancy, lactation, or planning to get pregnant.
Sites / Locations
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ginkgo and aspirin
aspirin
Arm Description
Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14. The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours;combined with Acetylsalicylic acid (Aspirin) given at a dose of 100 mg per day for 90 days.
Patients in the aspirin group received the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
Outcomes
Primary Outcome Measures
Proportion of subjects with NIHSS scores or NIHSS scores
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) scores decrease ≥5 (Δ ≥ 5) or Modified Rankin Scale (mRS) scores decrease ≥2(Δ ≥ 2) from baseline to randomized 90 days.
Secondary Outcome Measures
PL-11 AA at 24 hours and day 14
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid.
PL-11 ADP at 24 hours and day 14
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of adenosine diphosphate.
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.
PL-11 COL at 24 hours and day 14
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of collagen.
PL-11 EPI at 24 hours and day 14
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of epinephrine.
Full Information
NCT ID
NCT05531942
First Posted
September 2, 2022
Last Updated
July 12, 2023
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05531942
Brief Title
Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke
Official Title
Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke:A Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yueyang Integrated Medicine Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(100mg once/day D1-D14) in combination, while the other half will receive aspirin(100mg once/day D1-D14).
Detailed Description
This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 70 patients with acute ischemic stroke (5<NIHSS < 24), 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 was diluted with 250ml physiological saline,intravenous drip for about 3 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. The trial is anticipated to complete in 10 months from the first subject recruitment , with 70 subjects recruited. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ginkgo and aspirin
Arm Type
Active Comparator
Arm Description
Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14. The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours;combined with Acetylsalicylic acid (Aspirin) given at a dose of 100 mg per day for 90 days.
Arm Title
aspirin
Arm Type
Placebo Comparator
Arm Description
Patients in the aspirin group received the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
Intervention Type
Drug
Intervention Name(s)
Ginkgo Diterpene Lactone Meglumine Injection
Other Intervention Name(s)
YinxingErtieneizhiPu'an Zhusheye
Intervention Description
The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours.
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Other Intervention Name(s)
Aspirin
Intervention Description
Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.
Primary Outcome Measure Information:
Title
Proportion of subjects with NIHSS scores or NIHSS scores
Description
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) scores decrease ≥5 (Δ ≥ 5) or Modified Rankin Scale (mRS) scores decrease ≥2(Δ ≥ 2) from baseline to randomized 90 days.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
PL-11 AA at 24 hours and day 14
Description
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid.
Time Frame
24 hours,14 days
Title
PL-11 ADP at 24 hours and day 14
Description
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of adenosine diphosphate.
Time Frame
24 hours,14 days
Title
New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)
Description
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
14 days
Title
PL-11 COL at 24 hours and day 14
Description
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of collagen.
Time Frame
24 hours,14 days
Title
PL-11 EPI at 24 hours and day 14
Description
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of epinephrine.
Time Frame
24 hours,14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of AIS within 4.5-48 h of symptom onset;
Age >40 years, and gender not limited;
A score of 5-24 points on the National Institute of Health Stroke Scale (NIHSS);
Written informed consent was available before enrolment.
Exclusion Criteria:
Cardiogenic cerebral embolism;
AIS caused by other definite causes (e.g., arterial dissection, vasculitis, vascular malformation, etc.) or undetermined etiology;
Treated with thrombolysis or intravascular therapy, or with arteriovenous bridging after onset;
Under dual antiplatelet therapy or anticoagulant therapy;
A score of more than 2 on the modified Rankin Scale (mRS) (scores range from 0 [no symptoms] to 6 [death]) before the occurrence of AIS;
Allergy or contraindication to GDLI or aspirin;
Patients with active bleeding or bleeding tendency, malignancies, severe liver (the serum level of AST and/or ALT > 2 times the upper limit of normal), or renal failure (the serum level of creatinine > 1.5 times the upper limit of normal or GFR < 40 ml/min/1.73m2);
Anticipated requirement for long-term nonstudy antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function;
Severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months;
Planned surgery or interventional treatment requiring cessation of the study drug;
Pregnancy, lactation, or planning to get pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunxiang Chen, Master of Medicine
Phone
+8618616537797
Email
768449109@qq.com
Facility Information:
Facility Name
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Zhou, M.D.
Email
pdzhoujia@163.com
First Name & Middle Initial & Last Name & Degree
Ke Wang, Ph D
Email
wangke8430@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke
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