Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2021-12-31

Brief Summary

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Previous clinical studies have confirmed that revascularization or recanalization rate after intravenous thrombolysis is closely related to the formation of thrombus, which also results in poor neurological function after thrombolysis. Platelet activating factor (PAF) strong platelet aggregation may be involved in thrombosis. Formation process. The main components of Ginkgolide injection (Ginkgo) are ginkgolide, ginkgolides A, ginkgolides B and ginkgolides C. Ginkgo biloba lactone can antagonize PAF and has strong anti-platelet aggregation. . Therefore, it can be speculated that ginkgolides injection combined with alteplase intravenous thrombolysis may improve the recanalization rate after thrombolysis and reduce the reocclusion rate.

In addition, clinical studies have also found that ginkgolide injection has a good auxiliary effect on hypertensive intracerebral hemorrhage, which can regulate inflammatory factors such as IL-6, TNF-α and high-sensitivity C-reactive protein (CRP) in patients. Recovery of neurological function in patients. It is well known that TNF-α, IL-β, IL-1, IL-6, IFN-γ, etc. are all inflammatory factors associated with reperfusion injury. Therefore, we speculate that ginkgolides injection may also regulate inflammatory factors associated with reperfusion injury, such as IL-6, TNF-α, thereby reducing reperfusion injury, thereby improving patient prognosis.

The aim of this study was to determine the clinical efficacy of ginkgolides injection combined with alteplase in the treatment of acute ischemic stroke, and to improve the prognosis of patients with thrombolysis.

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Detailed Description

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Conditions

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Intravenous Alteplase Thrombolysis Neurological Improving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ginkgolide group

ginkgolide plus alteplase

Group Type EXPERIMENTAL

ginkgolide

Intervention Type DRUG

ginkgolide plus alteplase

control

alteplase

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ginkgolide

ginkgolide plus alteplase

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age over 18 years old, clinically diagnosed as acute ischemic stroke;
2. in accordance with the indications for intravenous thrombolysis;
3. The patient or family member signs an informed consent form.

Exclusion Criteria

1. Patients with transient ischemic attack;
2. Imaging examination of patients with cerebral hemorrhage
3. patients with cerebral arteritis
4. ALT, AST ≥ 3 times the upper limit of normal value, Cr ≥ 1.5 times the upper limit of normal value
5. There is a tendency to bleed, and severe bleeding has occurred within 3 months
6. Patients with ginkgo drugs, alcohol, glycerol allergies or allergies
7. Patients with pregnancy plans, pregnancy and breastfeeding
8. Patients who participated in other drug clinical studies in the past month
9. Patients considered by the investigator to be unfit to participate in the clinical study (eg, mental, abnormal, etc.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No