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Completed

NCT Number: NCT03772847

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

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.

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Key information

Conditions

Intravenous Alteplase Thrombolysis Neurological Improving

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Min Lou

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

ginkgolide

Drug

ginkgolide plus alteplase

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Changxing People's Hospital
  • Dongyang People's Hospital
  • Haiyan People's Hospital
  • Taizhou First People's Hospital
  • The Central Hospital of Lishui City
  • The First People's Hospital of Huzhou
  • The Second Affiliated Hospital of Jiaxing University
  • Tongxiang First People's Hospital
  • Tongxiang Second People's Hospital

Registry information

Acronym: GIANT

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 11, 2018
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.