Intravenous thrombolysis
DrugNot applicable as this is an observational study.
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NCT Number: NCT07536074
Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke
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.
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Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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).
Treatment and study plan
Primary outcomes
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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).
Secondary outcomes
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Level of disability
Time frame: 90±14 days
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).
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The modified Rankin Scale score (mRS) 0-2
Time frame: 90±14 days
The proportion of mRS score 0-2 at 90±14 days
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The modified Rankin Scale score (mRS) 0-3
Time frame: 90±14 days
The proportion of mRS score 0-3 at 90±14 days
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Change in neurologic deficit (NIHSS score) at 24 hours
Time frame: 24±12 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.
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Change in neurologic deficit (NIHSS score) at 7 days or discharge
Time frame: 7±1 days
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.
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The modified Rankin Scale score (mRS) 0-1 at 1 year
Time frame: 1 year ± 60 days
The proportion of mRS score 0-1 at 1 year ± 60 days
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Stroke recurrence within 90 days
Time frame: 90±14 days
Stroke recurrence and time to recurrence within 90 days
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Stroke recurrence within 1 year
Time frame: 1 year ± 60 days
Stroke recurrence and time to recurrence within 1 year
Other outcomes
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Symptomatic intracranial hemorrhage
Time frame: 36 hours
Rate of symptomatic intracranial hemorrhage within 36 hours after intravenous thrombolysis (European Cooperative Acute Stroke Study [ECASS] III classification)
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Any intracranial hemorrhage
Time frame: 36 hours
Rate of any intracranial hemorrhage within 36 hours after intravenous thrombolysis
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Serious adverse events during hospitalization
Time frame: 7±1 days
Safety will be assessed according to common terminology criteria for adverse events (CTCAE)
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Mortality within 90 days
Time frame: 90±14 days
All-cause mortality within 90 days
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Mortality within 1 year
Time frame: 1 year ± 60 days
All-cause mortality within 1 year
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Other
Registry information
Official study title
Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke (EXTEND-IVT Registry)
Acronym: EXTEND-IVT
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Apr 17, 2026
- Registry last updated
- Apr 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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