Acute Anterior Circulation Ischemic Stroke
Conditions
Interventions
Intervention group:From Day 1 to Day 14 participants will receive 25?mg of Ginkgolide injection once daily.
Placebo group:From Day 1 to Day 14 participants will receive a placebo matching the Ginkgolide injection once daily
Sponsors
Xuanwu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years; 2) Patients with acute ischemic stroke who are scheduled to undergo endovascular treatment; 3) Time from symptom onset (last-known-well) to randomization within 24 hours; 4) Occlusion of the intracranial segment of the internal carotid artery and/or M1 segment of the middle cerebral artery confirmed by computed tomography angiography (CTA) magnetic resonance angiography (MRA) or digital subtraction angiography (DSA) including tandem occlusions involving both intracranial and extracranial vessels; 5) Baseline Alberta Stroke Program Early CT Score (ASPECTS) =6; 6) Baseline National Institutes of Health Stroke Scale (NIHSS) score =6; 7) The patient or the patients legally authorized representative is able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Modified Rankin Scale (mRS) score >1 prior to the index stroke; 2) Patients diagnosed with chronic occlusion or arterial dissection based on medical history prior imaging or clinical judgment; 3) Evidence of any intracranial hemorrhage on neuroimaging; 4) Female patients who are pregnant or breastfeeding; 5) History of gastrointestinal or genitourinary bleeding within 1 month prior to stroke onset; 6) History of major surgery within 14 days prior to stroke onset; 7) History of severe hepatic or renal dysfunction (defined as alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 times the upper limit of normal for hepatic dysfunction; serum creatinine [Scr] >2 times the upper limit of normal for renal dysfunction); 8) Life expectancy of less than 6 months; 9) Known allergy to the investigational drug its excipients ginkgo-based preparations or iodinated contrast agents; 10) Participation in another clinical trial involving drugs medical devices or surgical interventions within the past 30 days; 11) Unlikely to complete the 90-day follow-up as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with favorable outcome (mRS 0–2) at day 90; | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-5L quality of life score at day 90;Proportion of mRS 0–1 at day 90;Change in NIHSS score from baseline at 48h;Change in NIHSS score from baseline at 24h;Change in NIHSS score from baseline at day 7;Shift analysis of mRS score at day 90;Change in NIHSS score from baseline at day 14 or discharge; | — |
Countries
China
Contacts
Public ContactChen Zhou
Xuanwu Hospital of Capital Medical University
Outcome results
None listed