Ischemic Stroke, Acute
Conditions
Keywords
Shuxuetong Injection, Intravenous Thrombolysis, Patient Registry
Brief summary
Acute ischemic stroke is one of the main diseases leading to high risk of disability and morbidity worldwide. Since intravenous thrombolysis(IVT) can effectively improve the long-term functional prognosis of acute ischemic stroke(AIS), IVT within 4.5 hours of onset has been widely recommended by international guidelines. Although 35-53% of AIS patients achieve functional independence after receiving IVT, there are still a large number of patients who are disabled or even dead, and nearly 70% of patients have ineffective recanalization. Therefore, there is an urgent need for therapeutic drugs after IVT to further improve the prognosis and reduce the burden of AIS. Shuxuetong injection is widely used in China in patients with AIS after IVT, but the situation in real clinical practice is unclear. Therefore, the study aims to evaluate the effectiveness and safety of Shuxuetong Injection in patients with AIS treated with intravenous alteplase and tenecteplase, and obtain high-quality clinical evidence.
Interventions
According to clinical real treatment records
Sponsors
Dongzhimen Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients aged ≥18 years * Diagnosis of acute ischemic stroke * Receiving alteplase or tenecteplase treatment ≤ 4.5 hours of onset * Signed informed consent by patient or legally authorized representatives
Exclusion criteria
* Having received or planing to undergo endovascular therapy (including mechanical thrombectomy, arterial thrombolysis, angioplasty, etc.) * Life expectancy is less than 90 days * Other factors that the researchers think are not suitable for participating in the research * Currently receiving any experimental treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of mRS (0-1) | 90±7 days | The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of mRS (0-2) | 90±7 days | — |
| Proportion of mRS (0-1) or returning to baseline | 90±7 days | — |
| Distribution of mRS | 90±7 days | — |
| Change of NIHSS | baseline, 14 days or the day of discharge | The change in the National Institute of Health Stroke Scale (NIHSS) scores from baseline to 14 days or the day of discharge. The NIHSS score ranges from 0 (best score) to 42 (worst score). |
| BI | 90±7 days | The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score). |
| Total mortality | Within 90 days | The occurrence of mortality of any cause within 90 days. |
| Serious Adverse Events | Within 90 days | The occurrence of serious adverse events including any event resulting in prolonged hospital time, permanent damage to the body system or organ, a life-threatening condition or death within 90 days. |
Countries
China
Outcome results
None listed