Intravenous Alteplase Thrombolysis Clinical Trial
— GIANTOfficial title:
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
| Verified date | July 2021 |
| Source | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1189 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | May 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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.) |
| Country | Name | City | State |
|---|---|---|---|
| China | Min Lou | Hangzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Changxing People's Hospital, Dongyang People's Hospital, Haiyan People's Hospital, Huzhou First People's Hospital, Taizhou First People's Hospital, The Central Hospital of Lishui City, The Second Affiliated Hospital of Jiaxing University, Tongxiang First People's Hospital, Tongxiang Second People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2 | mRS 0-6, higher indicate worse outcome | 90 days | |
| Secondary | 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 | |
| Secondary | recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up | 3 months | ||
| Secondary | incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism) | 1 year |