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

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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

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date March 20, 2020
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
  • 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
  • recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up [ Time Frame: 3 months ]
  • incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism) [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
Official Title  ICMJE Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intravenous Alteplase Thrombolysis
  • Neurological Improving
Intervention  ICMJE Drug: ginkgolide
ginkgolide plus alteplase
Study Arms  ICMJE
  • Experimental: ginkgolide group
    ginkgolide plus alteplase
    Intervention: Drug: ginkgolide
  • No Intervention: control
    alteplase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2018)
1120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Min Lou, PhD +86 0571 87784810 loumingxc@vip.sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03772847
Other Study ID Numbers  ICMJE Yan 2018-015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ze Xin Chen 2nd affiliated hospital of Zhejiang University,School of Medicine
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP