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

Phase 4

Completed

• Conditions: Intravenous Alteplase Thrombolysis; Neurological Improving
• Interventions: Drug: ginkgolide

• Registration Number: NCT03772847
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-31
• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-12-09
• Study First Posted: 2018-12-11
• Primary Completion: 2020-05-01
• Status Verified: 2021-07
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1189

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ginkgolide group	ginkgolide	ginkgolide plus alteplase

Primary Outcome Measures

Name	Time	Method
proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2	90 days	mRS 0-6, higher indicate worse outcome

Secondary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days	14 days	NIHSS 0-42, and higher indicate worse outcome
incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism）	1 year
recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up	3 months

Trial Locations

Locations (1)

Min Lou; 🇨🇳 Hangzhou, Zhejiang, China