A Multicenter, Retrospective, Observational Cohort Study on Intravenous Thrombolysis Beyond the Time Window for Acute Ischemic Stroke

NCT07419997 | Recruiting

• 1 other identifier: XMEC-2025-006
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, retrospective, observational cohort study on intravenous thrombolysis beyond the time window for acute ischemic stroke

Conditions

Stroke

Keywords

Acute ischemic stroke; Alteplase; Tenecteplase; Stroke at 4.5 to 24 Hours

Outcome Measures

Primary Outcomes (1)

• Proportion of study participants with mRS scores of 0 - 1

  Proportion of study participants with mRS scores of 0 - 1

  at 90 (±7) days

Secondary Outcomes (5)

• Distribution of mRS scores ranging from 0 to 6

  at 90 (±7) days

• Proportion of study participants with mRS scores of 0 - 2

  at 90 (±7) days

• The proportion of study participants with a NIHSS score of ≤1 or a decrease of ≥8 points compared to the baseline

  at 24 (±12) hours

• mortality rate

  at 90 (±7) days

• Symptomatic intracranial hemorrhage

  within 36 hours

Study Arms (2)

Alteplase group

The research participants received Alteplase for Acute Ischemic Stroke at 4.5 to 24 Hours

Tenecteplase group

The research participants received Tenecteplase for Acute Ischemic Stroke at 4.5 to 24 Hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the survey, each center has at least 100 cases of thrombolysis with alteplase or tenecteplase for Acute Ischemic Stroke at 4.5 to 24 Hours each year. Data will be collected for 5 years, and it is estimated that a total of no less than 2,000 cases will be included.

1. Patients with acute ischemic stroke, regardless of gender; 2. Age ≥ 18 years old; 3. Time from onset to treatment within 4.5 - 24 hours (the onset time refers to the last time when they appeared normal); 4. Complete relevant clinical data (including gender, age, mRS, NIHSS, etc.).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University, Beijing, Beijing 100053

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xin Xing, MD

CONTACT

01083198082; drxingxin@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)