Acute Ischemic StrokeNCT07098143
An Application Provides Personalized Suggestions Based on Secondary Prevention Risk Factors to Stroke Patients
A study testing Risk factor management in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
Trial summary
This study applied an application that provides personalized suggestions and explore the effect of this actual intervention on reducing the risk of stroke recurrence Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Risk factor management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,092 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Aug 2028
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 to 80, with no gender restrictions;
- Acute ischemic stroke inpatients within 2 weeks of onset, where the onset time is the time when stroke symptoms appear or the last known normal time of the patient (when it is an onset during sleep or the symptom onset time cannot be accurately obtained due to aphasia, impaired consciousness, etc.);
- Confirmed diagnosis of ischemic stroke by CT or MRI of the brain within 2 weeks after symptom onset; ④ Local residents (residing for ≥6 months); ⑤ Patients who voluntarily participate in the study, have high compliance, and can sign the informed consent form;
- Patients who own a smartphone or other smart devices.
Who cannot join
- Patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases;
- Known pregnant or lactating women, or those who tested positive on a pregnancy test before cluster randomization;
- Patients with other conditions that may affect participation in the trial (e.g., refractory hypertension, severe aphasia, etc.);
- Patients undergoing psychiatric/psychological treatment that may contaminate the results; ⑤ Patients with a life expectancy of less than one year (e.g., coexisting malignant tumors, severe cardiopulmonary diseases, etc.);
- Patients already participating in other interventional clinical studies that may influence the outcome assessment; ⑦ Patients for whom the investigator deems unsuitable for participation in this study or who may pose significant risks to the patients (e.g., cognitive impairment preventing understanding and/or compliance with the study procedures and/or follow-up).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Individualized Risk Factor Management Application for Reducing the Recurrence Risk of Stroke: A Multicenter, Randomized Controlled Trial Study
This study applied an application that provides personalized suggestions and explore the effect of this actual intervention on reducing the risk of stroke recurrence
Read the detailed description
This study applied an application that provides personalized suggestions based on participant's own secondary prevention risk factors status to stroke patients, enabling them to promptly take protective measures. And explore the effect of this actual intervention on reducing the risk of stroke recurrence after one year, as well as changes in other health-related indicators.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Risk factor management
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factor managementOther
Receive individualized prevention risk factor management information for stroke through the application
| Study group | Role | What they receive |
|---|---|---|
| Risk factor management group | Experimental | Not described Receives: Other: Risk factor management |
| Routine education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence rate of stroke
Measured: Intervention at the 1-year
Secondary outcomes (18)
3-month, 6-month, 9-month recurrence rate of stroke
Measured: Intervention at 3-month, 6-month, 9-month
Health literacy scale score
It is used to assess patients' understanding about secondary prevention risk factors. The lower the score, the less they understand or are concerned about it
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
System usability scale score
It is used to understand the subjects' satisfaction and usability evaluation of the intelligent program. The higher the score, the better the evaluation
Measured: Intervention at 3-month, 6-month, 9-month and 1-year
Blood pressure
Systolic and diastolic blood pressure will be measured using a standard automated sphygmomanometer
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Electrocardiogram (ECG) parameters
Electrocardiogram (ECG) will be performed to assess cardiac electrical activity. Specific parameters will be analyzed, such as heart rate (beats per minute (bpm)), QT interval (milliseconds (ms)), PR interval (milliseconds (ms)), QRS duration (milliseconds (ms))
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Fasting blood glucose
Fasting plasma glucose levels will be measured to assess glycemic control
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Prothrombin time
Prothrombin time (PT) will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of 11.0 to 13.0 seconds
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
C-reactive protein
Blood samples will be analyzed using immunoassay techniques on automated analyzers
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Modified rankin scale score
The functional recovery of patients was evaluated using the modified rankin scale. The higher the score, the more serious it is
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
NIH stroke scale score
The neurological deficits on the NIHSS scale indicate that the higher the score, the more severe the stroke
Measured: Baseline
European five-dimensional five-level health scale score
It is used to assess an individual's health-related quality of life, consisting of two parts: a questionnaire and a visual analog scale (VAS). The questionnaire includes five dimensions, where higher scores indicate worse health status. The visual analog scale asks respondents to rate their overall health on a 0-100 scale, with higher scores reflecting better self-rated health status.
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Minimum mental state examination
It is used to screen patients' cognitive conditions. The lower the score, the worse the cognition
Measured: Baseline; Intervention at 6-month and 1-year
Social support rate scale score
It is used to understand the support that patients receive in society, and the higher the score, the more support they receive
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Depression anxiety stress scales - 21 score
It is used to understand the patient's emotional state. The higher the score, the worse the mood
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Activated partial thromboplastin time
Activated partial thromboplastin time (aPTT) will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of 26.0 to 36.0 seconds, and may vary slightly depending on the reagents or testing techniques used.
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
International normalized ratio
International normalized ratio (INR) will be assessed using standard coagulation tests, it reflects the coagulation function, ,、 and the reference range for healthy people is 0.8 to 1.2, and may vary slightly depending on the medication or disease status.
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Platelet count
Platelet count will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of (100～300）×10^9/L.
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
D-dimer
D-dimer will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of <0.3mg/L, and may vary slightly depending on the reagents or testing techniques used.
Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,092 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwei Hao, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098143
- Sponsor's protocol ID
- [2024]444-003-1-2
- Status last verified
- Sep 2025
- First submitted
- 19 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Risk Factor Management Application for Reducing the Recurrence Risk of Stroke: A Multicenter, Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07098143
- Acronym / sponsor ID
- [2024]444-003-1-2
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,092 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Aug 2025 (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 applied an application that provides personalized suggestions and explore the effect of this actual intervention on reducing the risk of stroke recurrence
Detailed description
This study applied an application that provides personalized suggestions based on participant's own secondary prevention risk factors status to stroke patients, enabling them to promptly take protective measures. And explore the effect of this actual intervention on reducing the risk of stroke recurrence after one year, as well as changes in other health-related indicators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk factor management group | Experimental | Other: Risk factor management |
| Routine education | No intervention | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 40 to 80, with no gender restrictions;
Key exclusion criteria (5 listed)
- Patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases;
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 |
|---|---|---|
| Risk factor managementReceive individualized prevention risk factor management information for stroke through the application | Other | Risk factor management group |
Primary outcome
1-year recurrence rate of stroke
Time frame: Intervention at the 1-year
18 secondary outcomes
3-month, 6-month, 9-month recurrence rate of stroke
Time frame: Intervention at 3-month, 6-month, 9-month
Health literacy scale score
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
System usability scale score
Time frame: Intervention at 3-month, 6-month, 9-month and 1-year
Blood pressure
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Electrocardiogram (ECG) parameters
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Fasting blood glucose
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Prothrombin time
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
C-reactive protein
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Modified rankin scale score
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
NIH stroke scale score
Time frame: Baseline
European five-dimensional five-level health scale score
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Minimum mental state examination
Time frame: Baseline; Intervention at 6-month and 1-year
Social support rate scale score
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Depression anxiety stress scales - 21 score
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Activated partial thromboplastin time
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
International normalized ratio
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
Platelet count
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
D-dimer
Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year
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 5 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Junwei Hao study chair
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing Risk factor management in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Junwei Hao (010-83198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence rate of stroke (time frame: Intervention at the 1-year). 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 5 Sep 2025.