Ischemic StrokeNCT05410457
Different Treatment Strategies on Prognosis of Acute Ischemic Stroke(AISDTS)
An observational study of Ischemic Stroke, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
AISDTS is a prospective registry study, in which clinical information, examination and imaging data of patients with acute ischemic stroke receiving different treatment strategies were collected, grouped and statistically analyzed, and corresponding clinical prediction models were constructed to explore the role of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- Type of treatment
- Injection or infusion
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2022to 24 Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital for ischemic stroke were enrolled.
Who may be able to join
- A) ≥18 years of age; B) hospital admission for ischemic stroke; C) Signed informed consent.
Who cannot join
- A) patients with incomplete clinical information; B) hospitalization observation time less than 24 hours; C) recent trauma, severe inflammation, severe liver and kidney dysfunction, progressive malignance and other serious diseases; D) baseline mRS score>2; E) informed consent is not signed.
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
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
Junshan Zhou, M.D., +86025-87726218, zhjsh333@126.com
Qiwen Deng, M.D., +86025-87726218, qiw_deng@163.com
About this study
Official title: Study on the Effect of Different Treatment Strategies on Prognosis of Acute Ischemic Stroke(AISDTS)
AISDTS is a prospective registry study, in which clinical information, examination and imaging data of patients with acute ischemic stroke receiving different treatment strategies were collected, grouped and statistically analyzed, and corresponding clinical prediction models were constructed to explore the role of clinical biological indicators in the occurrence and development of stroke.
Read the detailed description
- To study which variable or variables (various clinical biological indicators) affect the prognosis of ischemic stroke patients;
- To study the differences in variables (various clinical evaluations, biological indicators, etc.) among patients receiving different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
- To study hemoglobin, mean erythrocyte volume, white blood cell count, neutrophil count, lymphocyte count, monocyte count, IL-2, IL-4, IL-6, IL-10, IFNγ, TNFα, C-reactive protein, serum iron and iron-related proteins (ferritin, transferrin, fibromodulin, ceruloplasmin), uric acid, amino acid, lipoprotein, homocysteine, vitamin D and other clinical indicators that correlated with acute ischemic stroke patients and different treatment groups were compared;
- To study the relationship between blood pressure changes at multiple time points from admission to discharge and clinical manifestations and prognosis of stroke patients, and to make comparison between groups;
- To study the relationship between ischemic stroke and other variables (clinical assessment, biological, genetic and neuroimaging) in different pathological types;
- To study the correlation between neuroimaging indicators and clinical evaluation, biomolecular, genetic and other variables;
- DNA and RNA were extracted from peripheral blood samples of patients with acute stroke for genetic related studies to explore the genetic susceptibility of young stroke and unexplained stroke;
- To study the role of one-stop multimodal-MRI in the assessment and diagnosis of patients with acute ischemic stroke;
- To study the adverse reactions (hemorrhage, embolus shedding, gastrointestinal ulcer) and stroke-related complications under different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
- To study the effect of Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) on inflammation and the prognosis in ischemic stroke patients.
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, clincial indicators, thrombolysis, thrombectomy, neuroimaging, genetics, one-stop multimodal-MRI, stroke related complications
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| thrombolysis group | Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 4.5 hours; D) received intravenous thrombolysis; E) signed informed consent. | |
| thrombectomy group | Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 24 hours; D) vascular assessment by CTA or multimodal MRI; E) received thrombectomy; F) signed informed consent. | |
| stent group | Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) vascular assessment by CTA or multimodal MRI; D) received stent implantation ; E) Signed informed consent. | |
| regular treatment group | Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) received regular medical treatment; D) signed informed consent. | |
| young stroke group | Inclusion criteria: a) age between 18 and 50 years of age (45/55Y); B) hospital admission due to ischemic stroke; C) received CT or MRI imaging assessment; D) signed informed consent. | |
| unexplained stroke group | Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) Received CT or MRI imaging assessment; D)TOAST was classified as unknown cause type (including two or more causes and no cause was found by auxiliary examination); E) signed informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the changes of prognosis of stroke patients under different treatment strategies
assessed by The Modified Rankin Score (mRS) of stroke patients [mild to wores ranging from 0 to 5, 6 represents death].
Measured: 3 months, 6 months, 12 months or 24 months
To assess the early neurological changes of ischemic stroke
change from baseline National Institute of Health stroke scalescore (NIHSS) [higher scores mean worse conditions]7 days or 14 days
Measured: 7 days or 14 days
Secondary outcomes (4)
To assess the incidence of recurrent stroke under different treatment strategies
record and analyze the incidence of recurrent stroke from 7 days-24 months
Measured: 7 days-24 months
To assess the types and incidence of adverse events of ischemic stroke patients
adverse reactions (hemorrhage, embolus shedding, gastrointestinal ulcer) and stroke-related complications under different treatment strategies
Measured: 3 days-24 months
To assess the correlation of RNA/DNA and age factor in acute ischemic stroke
DNA and RNA extracted from peripheral blood samples
Measured: 3 months
To assess the therapeutical effects of Edaravone dexborneol on inflammation and prognosis after acute ischemic stroke
The Modified Rankin Score score (mRS) of stroke patients [mild to wores ranging from 0 to 5, 6 represents death].
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start24 May 2022
- Primary completion24 Jun 2027 (estimated)
- Study completion24 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410457
- Sponsor's protocol ID
- AISDTS
- Status last verified
- Jan 2026
- First submitted
- 26 May 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Z, Sun C, Zhang Q, Ji L, Zhang Y, Li S, Gu M, Gao J, Huang Z, Wang M, Zhou J, Zhu L, Jiang T, Zhou Q, Deng Q. Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke. J Inflamm Res. 2026 Apr 30;19:590179. doi: 10.2147/JIR.S590179. eCollection 2026.
PubMed 42089099
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Different Treatment Strategies on Prognosis of Acute Ischemic Stroke(AISDTS)
- ClinicalTrials.gov ID
- NCT05410457
- Acronym / sponsor ID
- AISDTS
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, clincial indicators, thrombolysis, thrombectomy, neuroimaging, genetics, one-stop multimodal-MRI, stroke related complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 24 Jun 2027 (estimated)
- Study completion
- 24 Jun 2027 (estimated)
- First posted
- 8 Jun 2022 (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.
AISDTS is a prospective registry study, in which clinical information, examination and imaging data of patients with acute ischemic stroke receiving different treatment strategies were collected, grouped and statistically analyzed, and corresponding clinical prediction models were constructed to explore the role of clinical biological indicators in the occurrence and development of stroke.
Detailed description
- To study which variable or variables (various clinical biological indicators) affect the prognosis of ischemic stroke patients;
- To study the differences in variables (various clinical evaluations, biological indicators, etc.) among patients receiving different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
- To study hemoglobin, mean erythrocyte volume, white blood cell count, neutrophil count, lymphocyte count, monocyte count, IL-2, IL-4, IL-6, IL-10, IFNγ, TNFα, C-reactive protein, serum iron and iron-related proteins (ferritin, transferrin, fibromodulin, ceruloplasmin), uric acid, amino acid, lipoprotein, homocysteine, vitamin D and other clinical indicators that correlated with acute ischemic stroke patients and different treatment groups were compared;
- To study the relationship between blood pressure changes at multiple time points from admission to discharge and clinical manifestations and prognosis of stroke patients, and to make comparison between groups;
- To study the relationship between ischemic stroke and other variables (clinical assessment, biological, genetic and neuroimaging) in different pathological types;
- To study the correlation between neuroimaging indicators and clinical evaluation, biomolecular, genetic and other variables;
- DNA and RNA were extracted from peripheral blood samples of patients with acute stroke for genetic related studies to explore the genetic susceptibility of young stroke and unexplained stroke;
- To study the role of one-stop multimodal-MRI in the assessment and diagnosis of patients with acute ischemic stroke;
- To study the adverse reactions (hemorrhage, embolus shedding, gastrointestinal ulcer) and stroke-related complications under different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
- To study the effect of Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) on inflammation and the prognosis in ischemic stroke patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| thrombolysis group | – | –Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 4.5 hours; D) received intravenous thrombolysis; E) signed informed consent. |
| thrombectomy group | – | –Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 24 hours; D) vascular assessment by CTA or multimodal MRI; E) received thrombectomy; F) signed informed consent. |
| stent group | – | –Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) vascular assessment by CTA or multimodal MRI; D) received stent implantation ; E) Signed informed consent. |
| regular treatment group | – | –Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) received regular medical treatment; D) signed informed consent. |
| young stroke group | – | –Inclusion criteria: a) age between 18 and 50 years of age (45/55Y); B) hospital admission due to ischemic stroke; C) received CT or MRI imaging assessment; D) signed informed consent. |
| unexplained stroke group | – | –Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) Received CT or MRI imaging assessment; D)TOAST was classified as unknown cause type (including two or more causes and no cause was found by auxiliary examination); E) signed informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital for ischemic stroke were enrolled.
Key inclusion criteria (1 listed)
- A) ≥18 years of age; B) hospital admission for ischemic stroke; C) Signed informed consent.
Key exclusion criteria (1 listed)
- A) patients with incomplete clinical information; B) hospitalization observation time less than 24 hours; C) recent trauma, severe inflammation, severe liver and kidney dysfunction, progressive malignance and other serious diseases; D) baseline mRS score>2; E) informed consent is not signed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the changes of prognosis of stroke patients under different treatment strategies
Time frame: 3 months, 6 months, 12 months or 24 months
assessed by The Modified Rankin Score (mRS) of stroke patients [mild to wores ranging from 0 to 5, 6 represents death].
To assess the early neurological changes of ischemic stroke
Time frame: 7 days or 14 days
change from baseline National Institute of Health stroke scalescore (NIHSS) [higher scores mean worse conditions]7 days or 14 days
4 secondary outcomes
To assess the incidence of recurrent stroke under different treatment strategies
Time frame: 7 days-24 months
To assess the types and incidence of adverse events of ischemic stroke patients
Time frame: 3 days-24 months
To assess the correlation of RNA/DNA and age factor in acute ischemic stroke
Time frame: 3 months
To assess the therapeutical effects of Edaravone dexborneol on inflammation and prognosis after acute ischemic stroke
Time frame: 3 months
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 9 Apr 2026.
- Derived from this study: PubMed 42089099Li Z, Sun C, Zhang Q, Ji L, Zhang Y, Li S, Gu M, Gao J, Huang Z, Wang M, Zhou J, Zhu L, Jiang T, Zhou Q, Deng Q. Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke. J Inflamm Res. 2026 Apr 30;19:590179. doi: 10.2147/JIR.S590179. eCollection 2026.
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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.
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 Ischemic Stroke, run by Nanjing First Hospital, Nanjing Medical University 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 9 Apr 2026. 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 Qiwen Deng, M.D. (+86025-87726218, qiw_deng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the changes of prognosis of stroke patients under different treatment strategies (time frame: 3 months, 6 months, 12 months or 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410457, which also lists 1 linked publication.
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 9 Apr 2026.