The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic Stroke

NCT05663307 | Unknown Phase 2

• 1 other identifier: No.2020-134
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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

  90 days

Secondary Outcomes (1)

• New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)

  90 days

Study Arms (2)

Ginkgo diterpene lactone meglumine injection

ACTIVE COMPARATOR

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

Ginkgo diterpene lactone meglumine injection simulation

PLACEBO COMPARATOR

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

Interventions

Ginkgo diterpene lactone meglumine injection DRUG

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

Ginkgo diterpene lactone meglumine injection

Ginkgo diterpene lactone meglumine injection simulation DRUG

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

Ginkgo diterpene lactone meglumine injection simulation

Aspirin DRUG

plus aspirin at a dose of 100 mg per day for 90 days.

Also known as: Acetylsalicylic acid

Ginkgo diterpene lactone meglumine injection; Ginkgo diterpene lactone meglumine injection simulation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \> 40 years, and gender not limited;
• Within 48 hours of stroke onset of ischemic stroke;
• The first onset, or always not obvious legacy of stroke sequela;
• A score of 5-24 points on the National Institute of Health Stroke Scale (NIHSS)；
• Understand and voluntarily signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yan Han, Ph.D.

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Chunxiang Chen, M.D.

CONTACT

+8618616537797; 768449109@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: January 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)