StrokeTRAILBLAZERNCT07419997
A Multicenter, Retrospective, Observational Cohort Study on Intravenous Thrombolysis Beyond the Time Window for Acute Ischemic Stroke
An observational study of Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A multicenter, retrospective, observational cohort study on intravenous thrombolysis beyond the time window for acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 2,600 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2025to 29 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- Patients with acute ischemic stroke, regardless of gender;
- Age ≥ 18 years old;
- Time from onset to treatment within 4.5 - 24 hours (the onset time refers to the last time when they appeared normal);
- Complete relevant clinical data (including gender, age, mRS, NIHSS, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University, Beijing, Beijing 100053
Beijing, 100053
Xin Xing, MD, 01083198082, drxingxin@126.com
About this study
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
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study participants with mRS scores of 0 - 1
Proportion of study participants with mRS scores of 0 - 1
Measured: at 90 (±7) days
Secondary outcomes (5)
Distribution of mRS scores ranging from 0 to 6
Distribution of mRS scores ranging from 0 to 6
Measured: at 90 (±7) days
Proportion of study participants with mRS scores of 0 - 2
Proportion of study participants with mRS scores of 0 - 2
Measured: 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
The proportion of study participants with a NIHSS score of ≤1 or a decrease of ≥8 points compared to the baseline
Measured: at 24 (±12) hours
mortality rate
mortality rate
Measured: at 90 (±7) days
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage
Measured: within 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start29 Dec 2025
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419997
- Sponsor's protocol ID
- XMEC-2025-006
- Acronym
- TRAILBLAZER
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective, Observational Cohort Study on Intravenous Thrombolysis Beyond the Time Window for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07419997
- Acronym / sponsor ID
- TRAILBLAZER / XMEC-2025-006
- Conditions
- Stroke
- Keywords
- Acute ischemic stroke, Alteplase, Tenecteplase, Stroke at 4.5 to 24 Hours
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, retrospective, observational cohort study on intravenous thrombolysis beyond the time window for acute ischemic stroke
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Distribution of mRS scores ranging from 0 to 6
Time frame: at 90 (±7) days
Proportion of study participants with mRS scores of 0 - 2
Time frame: 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
mortality rate
Time frame: at 90 (±7) days
Symptomatic intracranial hemorrhage
Time frame: within 36 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Central Post-Stroke Pain, Stroke
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Xing, MD (01083198082, drxingxin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of study participants with mRS scores of 0 - 1 (time frame: at 90 (±7) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.