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

Zhejiang University

Status and phase: Completed; Phase 4

Conditions: Intravenous Alteplase Thrombolysis; Neurological Improving

Treatments: Drug: ginkgolide

Study type: Interventional

Funder types: Other

Identifiers

NCT03772847

Yan 2018-015

Details and patient eligibility

About

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.

Enrollment: 1,189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,189 participants in 2 patient groups

ginkgolide group

Experimental group

Description:

ginkgolide plus alteplase

Treatment:

Drug: ginkgolide

control

No Intervention group

Description:

alteplase