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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772847
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Intravenous Alteplase Thrombolysis Neurological Improving Drug: ginkgolide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: ginkgolide group
ginkgolide plus alteplase
Drug: ginkgolide
ginkgolide plus alteplase

No Intervention: control
alteplase



Primary Outcome Measures :
  1. proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2 [ Time Frame: 90 days ]
    mRS 0-6, higher indicate worse outcome


Secondary Outcome Measures :
  1. National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days [ Time Frame: 14 days ]
    NIHSS 0-42, and higher indicate worse outcome

  2. recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up [ Time Frame: 3 months ]
  3. incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism) [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772847


Contacts
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Contact: Min Lou, PhD +86 0571 87784810 loumingxc@vip.sina.com

Locations
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China, Zhejiang
Min Lou Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Zexin Chen    13757118366    HREC2013@126.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Ze Xin Chen 2nd affiliated hospital of Zhejiang University,School of Medicine
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03772847    
Other Study ID Numbers: Yan 2018-015
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No