Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke (EXTEND-IVT Registry)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 3,000
- Locations
- 2
- Primary Endpoint
- The modified Rankin Scale score (mRS) 0-1
Overview
Brief 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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Extended time window intravenous thrombolysis
Intervention: Intravenous Thrombolysis (Drug)
Outcomes
Primary Outcomes
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
- Level of disability(90±14 days)
- The modified Rankin Scale score (mRS) 0-2(90±14 days)
- The modified Rankin Scale score (mRS) 0-3(90±14 days)
- Change in neurologic deficit (NIHSS score) at 24 hours(24±12 hours)
- Change in neurologic deficit (NIHSS score) at 7 days or discharge(7±1 days)
- The modified Rankin Scale score (mRS) 0-1 at 1 year(1 year ± 60 days)
- Stroke recurrence within 90 days(90±14 days)
- Stroke recurrence within 1 year(1 year ± 60 days)