Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous Thrombolysis.
- Who it may be relevant to
- Registry conditions: Stroke, Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke (EXTEND-IVT Registry)
Overview
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.
Interventions
- Drug Intravenous Thrombolysis
Not applicable as this is an observational study.
Primary outcome measures
- The modified Rankin Scale score (mRS) 0-1 [Time frame: 90±14 days]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
- Liuyang Jili Hospital — Guankou
Identifiers
NCT: NCT07536074 · SYSKY-2026-177-01