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

Stroke, Acute Clinical Trial

— IVTIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131385
• Other study ID #: SWMU-2023-12
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: May 1, 2046

Study information

• Verified date: November 2023
• Source: The Affiliated Hospital Of Southwest Medical University
• Contact: Zhengzhou Yuan, MD
• Phone: +868303165661
• Email: coneuro[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 1, 2046
• Est. primary completion date: December 15, 2045
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No additional exclusion criteria.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

Drug:
• intravenous thrombolysis
Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase.

Locations

Country	Name	City	State
China	Affiliated Hospital of Southwest Medical University	Luzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhengzhou Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale (mRS) score	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)	90±7 days
Secondary	Excellent functional outcome	Proportion of subjects with mRS 0-1 at 90±7 days.	90±7 days
Secondary	Good functional outcome	Proportion of subjects with mRS 0-2 at 90±7 days.	90±7 days
Secondary	mRS 0-3	Proportion of subjects with mRS 0-3 at 90±7 days.	90±7 days
Secondary	Change of National Institutes of Health Stroke Scale (NIHSS)	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 24 hours.	24 hours
Secondary	Change of National Institutes of Health Stroke Scale (NIHSS)	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.	7 days
Secondary	Symptom-to-thrombolysis time	Time from onset of symptoms to thrombolytic therapy.	24 hours
Secondary	Door-to-Needle Time	Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.	24 hours
Secondary	Incidence of clinically significant intracranial hemorrhage	Incidence of sICH (Heidelberg criteria) measured at 36 hours	36 hours
Secondary	Incidence of any intracranial hemorrhage	Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours	36 hours
Secondary	All-cause mortality	All-cause mortality at 90±7 days	90±7 days
Secondary	Complications related to intravenous thrombolysis	Complications related to intravenous thrombolysis during hospitalization	up to 7 days