Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke

N/ANot Yet RecruitingNCT06861426

Ying Gao4,460 enrolled

Overview

The primary purpose of this study is to investigate the effectiveness of Ginkgo Diterpene Lactone Meglumine (GDLM) for patients with acute ischemic stroke (AIS) in real-world settings.

The randomized controlled trial (RCT) of GDLM for the treatment of AIS was published in JAMA Network Open, titled "Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial." This study provided valuable insights into the efficacy and safety of GDLM in improving functional recovery for patients with AIS. However, the generalizability of these findings to real-world medical settings remains unclear, as the trial was conducted under controlled conditions that may not fully reflect routine clinical practice. To address this gap, we will conduct this study to further explore the effectiveness of GDLM in a real medical environment. Using routine clinical care data for real-world evidence, we aim to investigate the treatment's impact on a broader and more diverse patient population. This approach will allow us to better understand the practical application of GDLM in everyday clinical settings, including its potential benefits and challenges when used outside the confines of a RCT.

Study Type

OBSERVATIONAL

Enrollment

4,460

Conditions

Acute Ischemic Stroke

Interventions

Ginkgo Diterpene Lactone MeglumineDRUG

The specific administration protocol (including time of initiation, dosage, and treatment duration) should be strictly adhered to as per the physician's prescription and meticulously documented in the case report forms (CRFs).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * aged ≥18 years, regardless of gender * within 48 hours of stroke onset of ischemic stroke * patient or their legally authorized representative (LAR) has signed informed consent or legally authorized oral consent with documentation Exclusion Criteria: * mRS score of 2 or more prior to onset * total hospital stay less than 7 days * use of other ginkgo-derived preparations except GDLM * current or planned participation in any other interventional clinical trials * inability to comply with study procedures due to documented psychiatric disorders or severe cognitive impairment

Locations (10)

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Harbin Second Hospital

Harbin, Heilongjiang, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Outcomes

Primary Outcomes

Proportion of patients with an mRS score of 0 or 1

Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 \[no symptoms\] to 5 \[severe disability\] when excluding mortality, with lower scores indicating better functional outcome)

Time frame: on day 90 after onset

Secondary Outcomes

Proportion of patients with an mRS score of 2 or less

Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 \[no symptoms\] to 5 \[severe disability\] when excluding mortality, with lower scores indicating better functional outcome)

Time frame: on day 90 after onset

Distribution of mRS scores

Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 \[no symptoms\] to 5 \[severe disability\] when excluding mortality, with lower scores indicating better functional outcome)

Time frame: on day 90 after onset

Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)

Time frame: within 90 days after onset

Mortality rate

Time frame: within 90 days after onset

Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)

Time frame: during hospital stay (up to 14 days)

Central Contacts

Sijin Wang, PHD

CONTACT

+86-17812051019 20230941128@bucm.edu.cn

Data from ClinicalTrials.gov

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