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

February 12, 2026 updated by: Xuanwu Hospital, Beijing
A multicenter, retrospective, observational cohort study on intravenous thrombolysis beyond the time window for acute ischemic stroke

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University, Beijing, Beijing 100053
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

  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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of study participants with mRS scores of 0 - 1
Time Frame: at 90 (±7) days
Proportion of study participants with mRS scores of 0 - 1
at 90 (±7) days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of mRS scores ranging from 0 to 6
Time Frame: at 90 (±7) days
Distribution of mRS scores ranging from 0 to 6
at 90 (±7) days
Proportion of study participants with mRS scores of 0 - 2
Time Frame: 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
Time Frame: at 24 (±12) hours
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
Time Frame: at 90 (±7) days
mortality rate
at 90 (±7) days
Symptomatic intracranial hemorrhage
Time Frame: within 36 hours
Symptomatic intracranial hemorrhage
within 36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

December 29, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMEC-2025-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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