Ischemic Stroke
Conditions
Brief summary
Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.
Interventions
Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 year; * Acute ischemic stroke confirmed by neuroimaging; * The time from last known well to treatment is within 4.5 hours; * NIHSS ≥ 6 at randomization; * Received intravenous tenecteplase (0.25mg/kg); * First stroke onset or past stroke without obvious neurological deficit (mRS≤1); * Signed informed consent.
Exclusion criteria
* Planed for endovascular treatment; * Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode； * Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection； * Pregnancy； * Allergy to the investigational drug(s)； * Comorbidity with other serious diseases; * Participating in other clinical trials within 3 months; * Patients not suitable for the study considered by researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1) | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of modified Rankin Scale (mRS) 0-2 | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| ordinal distribution of modified Rankin Scale (mRS) | 90±7 days | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome |
| change in National Institute of Health stroke scale (NIHSS) score | 24 (-6/+12) hours | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome |
| occurrence of early neurological improvement (ENI) | 24 (-6/+12) hours | ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score |
| new stroke or other vascular event(s) | 90±7 days | — |
| symptomatic intracranial hemorrhage (sICH) | 24 (-6/+12) hours | sICH was defined as any evidence of bleeding on the head computed tomographic scan associated with clinically significant neurological deterioration (≥4-point increase in NIHSS score). |
| major systemic bleeding events | 24 (-6/+12) hours | Bleeding leading to a decrease in hemoglobin ≥ 2 g/dL or transfusion of ≥ 2 units of blood. |
| any bleeding events | 24 (-6/+12) hours | Including skin and mucosal bleeding, gingival bleeding, bleeding at other organ sites, and other types of hemorrhage. |
| any intracranial hemorrhage | 10±2 days | Heidelberg Bleeding Classification |
| all-cause mortality | 90±7 days | death from any cause |
Countries
China
Outcome results
None listed