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

Study Description

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.

Condition or disease	Intervention/treatment
Ischemic Stroke, Acute	Drug: Shuxuetong Injection

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2008 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 90 Days
• Official Title: Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice: A Patient Registry
• Estimated Study Start Date: September 1, 2023
• Estimated Primary Completion Date: April 30, 2025
• Estimated Study Completion Date: December 31, 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Drug: Shuxuetong Injection; According to clinical real treatment records
Non-exposure group; The non-exposed group was defined as patients receiving guideline-standardized treatment after intravenous alteplase or tenecteplase.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke who received alteplase or tenecteplase within 4.5 hours of onset

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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Dongzhimen Hospital, Beijing

More Information

• Responsible Party: Ying Gao, MD, Dongzhimen Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT06018181
• Other Study ID Numbers: 2022YFC3501104-01
• First Posted: August 30, 2023
• Last Update Posted: August 30, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Keywords provided by Ying Gao, Dongzhimen Hospital, Beijing:

Shuxuetong Injection; Intravenous Thrombolysis; Patient Registry

Additional relevant MeSH terms:

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases