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

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.

Study Overview

• Status: Completed
• Conditions: Intravenous Alteplase Thrombolysis; Neurological Improving
• Intervention / Treatment: Drug: ginkgolide

• Study Type: Interventional
• Enrollment (Actual): 1189
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Min Lou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ginkgolide group; ginkgolide plus alteplase	Drug: ginkgolide; ginkgolide plus alteplase
No Intervention: control; alteplase

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days	NIHSS 0-42, and higher indicate worse outcome	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First People's Hospital of Huzhou; The Central Hospital of Lishui City; Taizhou First People's Hospital; The Second Affiliated Hospital of Jiaxing University; Changxing People's Hospital; Dongyang People's Hospital; Haiyan People's Hospital; Tongxiang Second People's Hospital; Tongxiang First People's Hospital
• Investigators: Study Chair: Ze Xin Chen, 2nd affiliated hospital of Zhejiang University，School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: Yan 2018-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No