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NCT Number: NCT06131385

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

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

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Southwest Medical University

Luzhou, 646000, China

Location status: Recruiting

Location contact

Zhengzhou Yuan

CONTACT

+868303165661

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No additional exclusion criteria.

Treatment and study plan

Intravenous thrombolysis

Drug

Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase.

Primary outcomes

  1. modified Rankin Scale (mRS) score

    Time frame: 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 outcomes

  1. Excellent functional outcome

    Time frame: 90±7 days

    Proportion of subjects with mRS 0-1 at 90±7 days.

  2. Good functional outcome

    Time frame: 90±7 days

    Proportion of subjects with mRS 0-2 at 90±7 days.

  3. mRS 0-3

    Time frame: 90±7 days

    Proportion of subjects with mRS 0-3 at 90±7 days.

  4. Change of National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 24 hours

    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.

  5. Change of National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 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.

  6. Symptom-to-thrombolysis time

    Time frame: 24 hours

    Time from onset of symptoms to thrombolytic therapy.

  7. Door-to-Needle Time

    Time frame: 24 hours

    Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.

  8. Incidence of clinically significant intracranial hemorrhage

    Time frame: 36 hours

    Incidence of sICH (Heidelberg criteria) measured at 36 hours

  9. Incidence of any intracranial hemorrhage

    Time frame: 36 hours

    Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours

  10. All-cause mortality

    Time frame: 90±7 days

    All-cause mortality at 90±7 days

  11. Complications related to intravenous thrombolysis

    Time frame: up to 7 days

    Complications related to intravenous thrombolysis during hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Zhengzhou Yuan, MD

CONTACT

[email protected]

+868303165661

Sponsors and collaborators

Lead sponsor

Zhengzhou Yuan

Other

Registry information

Acronym: IVTIS

Important dates

Study start
2023
Primary completion
2045
Study completion
2046
First posted
Nov 14, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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