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

• ClinicalTrials.gov Identifier: NCT06018181
• Recruitment Status: Not yet recruiting
• First Posted: August 30, 2023
• Last Update Posted: August 30, 2023
• Sponsor: Dongzhimen Hospital, Beijing
• Information provided by (Responsible Party): Ying Gao, Dongzhimen Hospital, Beijing

Tracking Information

• First Submitted Date: August 24, 2023
• First Posted Date: August 30, 2023
• Last Update Posted Date: August 30, 2023
• Estimated Study Start Date: September 1, 2023
• Estimated Primary Completion Date: April 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2023)

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).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 24, 2023)

• Proportion of mRS (0-2) [ Time Frame: 90±7 days ]
• Proportion of mRS (0-1) or returning to baseline [ Time Frame: 90±7 days ]
• Distribution of mRS [ Time Frame: 90±7 days ]
• 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).
• BI [ Time Frame: 90±7 days ]
  The Barthel Index (BI) score ranges from 0 (worst score) to 100 (best score).
• Total mortality [ Time Frame: Within 90 days ]
  The occurrence of mortality of any cause within 90 days.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice
• Official Title: Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A 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.

• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 90 Days
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset
• Condition: Ischemic Stroke, Acute

Intervention

Drug: Shuxuetong Injection

According to clinical real treatment records

Study Groups/Cohorts

• Exposure group

  The exposure group was defined as patients receiving Shuxuetong injection and guideline-standardized treatment after intravenous alteplase or tenecteplase.

  Mainly based on the following guidelines:(1)Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018; (2)Guidelines for secondary prevention of ischemic stroke and transient ischemic attack in China 2022.

  Intervention: Drug: Shuxuetong Injection
• Non-exposure group
  The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 24, 2023): 2008
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: April 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mingzhen Qin; 86-17801222857; qinmz@bucm.edu.cn

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06018181
• Other Study ID Numbers: 2022YFC3501104-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ying Gao, Dongzhimen Hospital, Beijing
• Original Responsible Party: Same as current
• Current Study Sponsor: Dongzhimen Hospital, Beijing
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Dongzhimen Hospital, Beijing
• Verification Date: August 2023