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

Primary Purpose

Intravenous Alteplase Thrombolysis, Neurological Improving

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ginkgolide
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intravenous Alteplase Thrombolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

  • Min Lou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ginkgolide group

control

Arm Description

ginkgolide plus alteplase

alteplase

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up
incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism)

Full Information

First Posted
September 5, 2018
Last Updated
May 5, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Dongyang People's Hospital, Haiyan People's Hospital, The Second Affiliated Hospital of Jiaxing University, Tongxiang Second People's Hospital, Tongxiang First People's Hospital, Changxing People's Hospital, The Central Hospital of Lishui City, The First People's Hospital of Huzhou, Taizhou First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03772847
Brief Title
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
Acronym
GIANT
Official Title
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Dongyang People's Hospital, Haiyan People's Hospital, The Second Affiliated Hospital of Jiaxing University, Tongxiang Second People's Hospital, Tongxiang First People's Hospital, Changxing People's Hospital, The Central Hospital of Lishui City, The First People's Hospital of Huzhou, Taizhou First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravenous Alteplase Thrombolysis, Neurological Improving

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ginkgolide group
Arm Type
Experimental
Arm Description
ginkgolide plus alteplase
Arm Title
control
Arm Type
No Intervention
Arm Description
alteplase
Intervention Type
Drug
Intervention Name(s)
ginkgolide
Intervention Description
ginkgolide plus alteplase
Primary Outcome Measure Information:
Title
proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2
Description
mRS 0-6, higher indicate worse outcome
Time Frame
90 days
Secondary Outcome Measure Information:
Title
National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days
Description
NIHSS 0-42, and higher indicate worse outcome
Time Frame
14 days
Title
recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up
Time Frame
3 months
Title
incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ze Xin Chen
Organizational Affiliation
2nd affiliated hospital of Zhejiang University,School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Min Lou
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34925044
Citation
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.
Results Reference
derived

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

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