NCT02526225

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,452

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

August 5, 2015

Last Update Submit

March 28, 2023

Conditions

Ischemic Stroke

Keywords

acute ischemic strokesafety and effectivenessGinkgo diterpene lactone meglumine injection

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .

    90 days

Secondary Outcomes (8)

  • 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 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,

  • Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .

    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

  • +3 more secondary outcomes

Study Arms (2)

ginkgo diterpene lactone meglumine injection

ACTIVE COMPARATOR

ginkgo diterpene lactone meglumine injection

Drug: Ginkgo diterpene lactone meglumine injection

Ginkgo diterpene lactone meglumine injection simulation

PLACEBO COMPARATOR

Ginkgo diterpene lactone meglumine injection simulation

Drug: Ginkgo diterpene lactone meglumine injection simulation

Interventions

Ginkgo diterpene lactone meglumine injectionDRUG

5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.

ginkgo diterpene lactone meglumine injection
Ginkgo diterpene lactone meglumine injection simulationDRUG

5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.

Ginkgo diterpene lactone meglumine injection simulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 80 years of age, and gender not limited。
  • Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease);
  • The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
  • 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;
  • Understand and voluntarily signed informed consent.

You may not qualify if:

  • 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.
  • The serious disturbance of consciousness (Ia NIHSS score 2 points or higher);
  • With hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis;
  • Serious abnormal liver and kidney function, liver function laboratory indexes of ALT \> 3 ULN, renal laboratory ULN Cr \> 1.5);
  • A history of mental illness or dementia patients;
  • 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;
  • Significant drug or alcohol abuse;
  • Allergic constitution, as well as to two or more drugs or food allergies;This medicine ingredients allergy or known;
  • Have pregnancy (check blood HCG positive screening tests, namely HCG \> 5 miu/mL), during the test preparation is pregnancy or lactation in women;
  • In the past three months in other clinical trials;
  • Researchers do not determine poor adherence, or any other suitable for patients to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (2)

  • Tian X, Xu Q, Xia X, Zhang Y, Zhao X, Wang A. Effect of ginkgo diterpene lactone meglumine on the quality of life in patients with acute ischemic stroke. Health Qual Life Outcomes. 2024 Nov 15;22(1):99. doi: 10.1186/s12955-024-02315-1.

    PMID: 39548582DERIVED

  • Zhang Q, Wang A, Xu Q, Xia X, Tian X, Zhang Y, Li X, Yang X, Wang X, Peng J, Li Y, Liu L, Jin S, Meng X, Zhao X; GDLM group. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2328828. doi: 10.1001/jamanetworkopen.2023.28828.

    PMID: 37578791DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • yongjun wang, M.D.

    Beijing Tiantan Hospital,Capital Medical University,Bgeijing,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Vice-President

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 18, 2015

Study Start

February 1, 2016

Primary Completion

May 1, 2018

Study Completion

August 31, 2019

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

CN(1)