Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）

Recruiting

• Conditions: Stroke, Acute
• Interventions: Drug: intravenous thrombolysis

• Registration Number: NCT06131385
• Lead Sponsor: Zhengzhou Yuan

Brief Summary

This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.

Detailed Description

IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-14
• Study Start: 2023-11-20
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28
• Primary Completion: 2045-12-15
• Study Completion: 2046-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.

Exclusion Criteria

• No additional exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemic stroke treated with intravenous thrombolysis	intravenous thrombolysis	All of acute ischemic stroke patients who treated with intravenous thrombolysis.

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS) score	90±7 days	Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant intracranial hemorrhage	36 hours	Incidence of sICH (Heidelberg criteria) measured at 36 hours
Excellent functional outcome	90±7 days	Proportion of subjects with mRS 0-1 at 90±7 days.
Good functional outcome	90±7 days	Proportion of subjects with mRS 0-2 at 90±7 days.
Incidence of any intracranial hemorrhage	36 hours	Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours
All-cause mortality	90±7 days	All-cause mortality at 90±7 days
Complications related to intravenous thrombolysis	up to 7 days	Complications related to intravenous thrombolysis during hospitalization
mRS 0-3	90±7 days	Proportion of subjects with mRS 0-3 at 90±7 days.
Change of National Institutes of Health Stroke Scale (NIHSS)	7 days	Change of National Institutes of Health Stroke Scale (NIHSS, a scale between 0 and 42 on which higher scores indicate more severe neurologic deficits) from baseline to 7 days.
Door-to-Needle Time	24 hours	Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.
Symptom-to-thrombolysis time	24 hours	Time from onset of symptoms to thrombolytic therapy.

Trial Locations

Locations (1)

Affiliated Hospital of Southwest Medical University; 🇨🇳 Luzhou, China