Skip to main content
OpenTrials
Completed

NCT Number: NCT06018181

Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Royal Integrative Medicine Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Shuxuetong Injection

Drug

According to clinical real treatment records

Primary outcomes

  1. Proportion of mRS (0-1)

    Time frame: 90±7 days

    The modified Rankin Scale (mRS) score ranges from 0 (best score) to 6 (worst score).

Secondary outcomes

  1. Proportion of mRS (0-2)

    Time frame: 90±7 days

  2. Proportion of mRS (0-1) or returning to baseline

    Time frame: 90±7 days

  3. Distribution of mRS

    Time frame: 90±7 days

  4. Change of NIHSS

    Time frame: 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).

  5. BI

    Time frame: 90±7 days

    The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).

  6. Total mortality

    Time frame: Within 90 days

    The occurrence of mortality of any cause within 90 days.

  7. Serious Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Official study title

Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Feb 27, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.