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

NCT03772847 | Completed Phase 4 DMC

• 1 other identifier: Yan 2018-015
• Study Type: interventional
• Target: 1,189
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Alteplase Thrombolysis; Neurological Improving

Outcome Measures

Primary Outcomes (1)

• proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2

  mRS 0-6, higher indicate worse outcome

  90 days

Secondary Outcomes (3)

• National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days

  14 days

• recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up

  3 months

• incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism）

  1 year

Study Arms (2)

ginkgolide group

EXPERIMENTAL

ginkgolide plus alteplase

Drug: ginkgolide

control

NO INTERVENTION

alteplase

Interventions

ginkgolide DRUG

ginkgolide plus alteplase

ginkgolide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Dongyang People's Hospital: collaborator
• Haiyan People's Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Tongxiang Second People's Hospital: collaborator
• Tongxiang First People's Hospital: collaborator
• Changxing People's Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• The First People's Hospital of Huzhou: collaborator
• Taizhou First People's Hospital: collaborator

Study Sites (1)

Min Lou

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Zhang X, Zhong W, Ma X, Zhang X, Chen H, Wang Z, Lou M. Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT). Front Pharmacol. 2021 Dec 3;12:792136. doi: 10.3389/fphar.2021.792136. eCollection 2021.

  PMID: 34925044 DERIVED

MeSH Terms

Interventions

Ginkgolides

Intervention Hierarchy (Ancestors)

Diterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ze Xin Chen

  2nd affiliated hospital of Zhejiang University，School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: December 11, 2018
• Study Start: July 31, 2018
• Primary Completion: May 1, 2020
• Study Completion: December 31, 2021
• Last Updated: May 6, 2022

Record last verified: 2021-07

Locations

CN (1)