Stroke, AcuteIVTISNCT06131385
Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）
An observational study of Stroke, Acute, run by Zhengzhou Yuan at 1 site in China.
Trial summary
This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- intravenous thrombolysis
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 1 May 2046
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with acute ischemic stroke who received intravenous thrombolysis will be included in the study and no additional exclusion criteria have been set.
Who may be able to join
- The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.
Who cannot join
- No additional exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, 646000
Zhengzhou Yuan, +868303165661
About this study
This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.
Read the detailed description
IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。
- Conditions
- Stroke, Acute
- Being tested
- intravenous thrombolysis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous thrombolysisDrug
Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke treated with intravenous thrombolysis | All of acute ischemic stroke patients who treated with intravenous thrombolysis. Receives: Drug: intravenous thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90±7 days
Secondary outcomes (11)
Excellent functional outcome
Proportion of subjects with mRS 0-1 at 90±7 days.
Measured: 90±7 days
Good functional outcome
Proportion of subjects with mRS 0-2 at 90±7 days.
Measured: 90±7 days
mRS 0-3
Proportion of subjects with mRS 0-3 at 90±7 days.
Measured: 90±7 days
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.
Measured: 24 hours
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.
Measured: 7 days
Symptom-to-thrombolysis time
Time from onset of symptoms to thrombolytic therapy.
Measured: 24 hours
Door-to-Needle Time
Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.
Measured: 24 hours
Incidence of clinically significant intracranial hemorrhage
Incidence of sICH (Heidelberg criteria) measured at 36 hours
Measured: 36 hours
Incidence of any intracranial hemorrhage
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours
Measured: 36 hours
All-cause mortality
All-cause mortality at 90±7 days
Measured: 90±7 days
Complications related to intravenous thrombolysis
Complications related to intravenous thrombolysis during hospitalization
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start20 Nov 2023
- Primary completion15 Dec 2045 (estimated)
- Study completion1 May 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhengzhou Yuan, The Affiliated Hospital Of Southwest Medical University
- Investigators
- Zhengzhou Yuan, Study chair, Department of Neurology, Affiliated Hospital of Southwest Medical University, Lu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131385
- Sponsor's protocol ID
- SWMU-2023-12
- Acronym
- IVTIS
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）
- ClinicalTrials.gov ID
- NCT06131385
- Acronym / sponsor ID
- IVTIS / SWMU-2023-12
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Zhengzhou YuanUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 15 Dec 2045 (estimated)
- Study completion
- 1 May 2046 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke treated with intravenous thrombolysis | – | Drug: intravenous thrombolysisAll of acute ischemic stroke patients who treated with intravenous thrombolysis. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute ischemic stroke who received intravenous thrombolysis will be included in the study and no additional exclusion criteria have been set.
Key inclusion criteria (1 listed)
- The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.
Key exclusion criteria (1 listed)
- No additional exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous thrombolysisIntravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase. | Drug | Acute ischemic stroke treated with intravenous thrombolysis |
Primary outcome
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)
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhengzhou Yuan study chair
Department of Neurology, Affiliated Hospital of Southwest Medical University, Lu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Zhengzhou Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengzhou Yuan, MD (+868303165661, coneuro@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) score (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.