Recruiting NCT06131385
Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intravenous thrombolysis.
- Who it may be relevant to
- Registry conditions: Stroke, Acute. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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。
Interventions
- Drug intravenous thrombolysis
Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase.
Primary outcome measures
- modified Rankin Scale (mRS) score [Time frame: 90±7 days]
Secondary outcome measures (11)
- Excellent functional outcome [Time frame: 90±7 days]
- Good functional outcome [Time frame: 90±7 days]
- mRS 0-3 [Time frame: 90±7 days]
- Change of National Institutes of Health Stroke Scale (NIHSS) [Time frame: 24 hours]
- Change of National Institutes of Health Stroke Scale (NIHSS) [Time frame: 7 days]
- Symptom-to-thrombolysis time [Time frame: 24 hours]
- Door-to-Needle Time [Time frame: 24 hours]
- Incidence of clinically significant intracranial hemorrhage [Time frame: 36 hours]
- Incidence of any intracranial hemorrhage [Time frame: 36 hours]
- All-cause mortality [Time frame: 90±7 days]
- Complications related to intravenous thrombolysis [Time frame: up to 7 days]
Eligibility criteria
Inclusion criteria
- The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.
Exclusion criteria
- No additional exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Affiliated Hospital of Southwest Medical University — Luzhou
Identifiers
NCT: NCT06131385 · SWMU-2023-12