StrokeEXTEND-IVTNCT07536074
Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke
An observational study of Stroke and Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
Trial summary
The EXTEND-IVT Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous thrombolysis administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic Stroke
- What is being tested?
- Intravenous Thrombolysis
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2026to Dec 2029
- How long will I take part?
- 1 Year
- 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: Adult patients (≥18 years) with acute ischemic stroke who receive intravenous thrombolysis more than 4.5 hours after last known well as part of standard clinical care.
Who may be able to join
- 1. Age ≥ 18 years
- 2. Clinical diagnosed of acute ischemic stroke
- 3. Time from last known well (LKW) to initiation of intravenous thrombolysis > 4.5 hours (including wake-up stroke and unwitnessed stroke)
- 4. Received intravenous thrombolysis
- 5. Provided written informed consent
Who cannot join
- 1. Any condition judged by the investigator to make the participant unsuitable for study participation or follow-up (e.g., psychiatric disorders, cognitive impairment, or emotional disturbances).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xinguang Yang contact
China2 sites
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Liuyang Jili Hospital
Guankou, Hunan
About this study
Official title: Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke (EXTEND-IVT Registry)
The EXTEND-IVT Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous thrombolysis administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China.
Read the detailed description
This prospective, multicenter, observational cohort registry enrolls adult patients (≥18 years) with acute ischemic stroke who receive intravenous thrombolysis more than 4.5 hours after last known well. Patient selection, imaging strategies, thrombolytic agent choice, dosing, and concomitant therapies are determined by treating physicians according to local clinical practice, without study-mandated intervention.
The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90 ± 14 days. This registry describes real-world patient characteristics, treatment patterns, and outcomes of extended time window intravenous thrombolysis, and explores factors associated with clinical outcomes to inform patient selection and future clinical practice.
- Conditions
- Stroke, Acute Ischemic Stroke
- Being tested
- Intravenous Thrombolysis
- 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.
Intravenous ThrombolysisDrug
Not applicable as this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Extended time window intravenous thrombolysis | Not described Receives: Drug: Intravenous Thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 or a return to baseline if the pre-stroke mRS score ≥2 at 90±14 days.
The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death).
Measured: 90±14 days
Secondary outcomes (8)
Level of disability
The shift analysis of the mRS scores at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death).
Measured: 90±14 days
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS score 0-2 at 90±14 days
Measured: 90±14 days
The modified Rankin Scale score (mRS) 0-3
The proportion of mRS score 0-3 at 90±14 days
Measured: 90±14 days
Change in neurologic deficit (NIHSS score) at 24 hours
Change in neurologic deficit (NIHSS score) from baseline to 24±12 hours after intravenous thrombolysis.
The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurologic deficit.
Measured: 24±12 hours
Change in neurologic deficit (NIHSS score) at 7 days or discharge
Change in neurologic deficit (NIHSS score) from baseline to 7±1 days or at discharge, if earlier.
The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurologic deficit.
Measured: 7±1 days
The modified Rankin Scale score (mRS) 0-1 at 1 year
The proportion of mRS score 0-1 at 1 year ± 60 days
Measured: 1 year ± 60 days
Stroke recurrence within 90 days
Stroke recurrence and time to recurrence within 90 days
Measured: 90±14 days
Stroke recurrence within 1 year
Stroke recurrence and time to recurrence within 1 year
Measured: 1 year ± 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityYong He, Principal investigator, Liuyang Jili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536074
- Sponsor's protocol ID
- SYSKY-2026-177-01
- Acronym
- EXTEND-IVT
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from the Principal Investigators (Prof. Yamei Tang and Prof. Yong He) upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke (EXTEND-IVT Registry)
- ClinicalTrials.gov ID
- NCT07536074
- Acronym / sponsor ID
- EXTEND-IVT / SYSKY-2026-177-01
- Conditions
- Stroke, Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Apr 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.
The EXTEND-IVT Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous thrombolysis administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China.
Detailed description
This prospective, multicenter, observational cohort registry enrolls adult patients (≥18 years) with acute ischemic stroke who receive intravenous thrombolysis more than 4.5 hours after last known well. Patient selection, imaging strategies, thrombolytic agent choice, dosing, and concomitant therapies are determined by treating physicians according to local clinical practice, without study-mandated intervention.
The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90 ± 14 days. This registry describes real-world patient characteristics, treatment patterns, and outcomes of extended time window intravenous thrombolysis, and explores factors associated with clinical outcomes to inform patient selection and future clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended time window intravenous thrombolysis | – | Drug: Intravenous Thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with acute ischemic stroke who receive intravenous thrombolysis more than 4.5 hours after last known well as part of standard clinical care.
Key inclusion criteria (5 listed)
- 1. Age ≥ 18 years
- 2. Clinical diagnosed of acute ischemic stroke
- 3. Time from last known well (LKW) to initiation of intravenous thrombolysis > 4.5 hours (including wake-up stroke and unwitnessed stroke)
- 4. Received intravenous thrombolysis
- 5. Provided written informed consent
Key exclusion criteria (1 listed)
- 1. Any condition judged by the investigator to make the participant unsuitable for study participation or follow-up (e.g., psychiatric disorders, cognitive impairment, or emotional disturbances).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ThrombolysisNot applicable as this is an observational study. | Drug | Extended time window intravenous thrombolysis |
Primary outcome
The modified Rankin Scale score (mRS) 0-1
Time frame: 90±14 days
The proportion of mRS score 0-1 or a return to baseline if the pre-stroke mRS score ≥2 at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death).
8 secondary outcomes
Level of disability
Time frame: 90±14 days
The modified Rankin Scale score (mRS) 0-2
Time frame: 90±14 days
The modified Rankin Scale score (mRS) 0-3
Time frame: 90±14 days
Change in neurologic deficit (NIHSS score) at 24 hours
Time frame: 24±12 hours
Change in neurologic deficit (NIHSS score) at 7 days or discharge
Time frame: 7±1 days
The modified Rankin Scale score (mRS) 0-1 at 1 year
Time frame: 1 year ± 60 days
Stroke recurrence within 90 days
Time frame: 90±14 days
Stroke recurrence within 1 year
Time frame: 1 year ± 60 days
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 17 Apr 2026.
- Individual participant dataSharing planned: Yes. The IPD will be available from the Principal Investigators (Prof. Yamei Tang and Prof. Yong He) upon reasonable request.
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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.
Xinguang Yang contact
Yamei Tang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Yong He principal investigator
Liuyang Jili Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Mingyi Bao (86-20-81332619, baomy@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale score (mRS) 0-1 (time frame: 90±14 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 17 Apr 2026.