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Not yet recruiting NCT07536074

Extended Time Window Intravenous Thrombolysis Registry for Acute Ischemic Stroke

Conditions: Stroke Acute Ischemic Stroke

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

trial.available_in: БГ
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.
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.
Who can participate
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).
Interventions
Intravenous Thrombolysis
DRUG
Locations 2
China (2)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou , Guangdong
Liuyang Jili Hospital
Guankou , Hunan
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.12.2029
Registry ID
NCT07536074
Source
clinicaltrials.gov
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