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Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYing Gao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

AIS patients within 48 hours of symptom onset from certified stroke centers across China

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Ginkgo Diterpene Lactone Meglumine

    Drug

    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).

Treatment groups

4,460 Participants
are divided into 2 treatment groups
Group A: GDLM group1 intervention
Group B: Non-exposed Group0 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Time frame
within 90 days after onset
4

Mortality rate

Time frame
within 90 days after onset

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ying Gao

Lead sponsor

Dongzhimen Hospital, Beijing

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: