Ischemic StrokeNCT07143149
Effect of the Intelligent Lipid Management Decision-support System on 1-year LDL-C Target Achievement in Ischemic Stroke or TIA Patients Under Evolocumab Treatment in China
A study testing the Intelligent Lipid Management Decision-support System in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study will conduct a cluster randomized controlled trial to Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack (TIA)
- What is being tested?
- the Intelligent Lipid Management Decision-support System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2025to 31 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years as of the screening date;
- Patients with non-cardioembolic ischemic stroke or TIA within 3 months prior to the screening date;
- Prescribed Evolocumab at physician's discretion;
- Signed informed consent.
Who cannot join
- Intracranial hemorrhagic diseases: such as cerebral hemorrhage, subarachnoid hemorrhage, etc.;
- Patients confirmed by baseline head CT or MRI to have hemorrhage or other pathological brain diseases, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis);
- Silent cerebral infarction without signs and symptoms;
- Participation in a clinical trial of another drug or device in the past 3 months or ongoing at the time of the screening date;
- Any prior use of Evolocumab or other PCSK9 inhibitor treatments within the past 6 months prior to the screening date;
- Life expectancy <12 months or unable to complete the research for other reasons as of the screening date;
- Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders;
- Refusal to participate in the enrollment survey.
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
Beijing Tiantan Hospital
Beijing
Jie Xu, 59978555 ext. 59975672, xujie@ncrcnd.org.cn
About this study
This study will conduct a cluster randomized controlled trial to Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.
Read the detailed description
Large scale randomized trials and systematic reviews have established the efficacy of lipid lowering therapy for acute ischemic stroke. However, adherence to these evidence-based performance measures is suboptimal and gaps in adherence to guideline recommended care are even greater in China. Multifaceted quality improvement interventions that address the barriers to care are effective in changing physician practices. Quality improvement interventions have demonstrated that stroke care quality can be improved by conducting interventions such as using clinical pathways, training physicians on evidence-based guidelines, auditing care delivery, and providing timely feedback.
Aim: To Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.
Intervention: The Intelligent Lipid Management Decision-support System primarily consists of an evidence-based clinical pathway. The evidence-based clinical pathway was written by a panel of stroke experts according to the published statements in peer-reviewed literature, consensus statements and guidelines. It was integrated into the care plan of each eligible stroke admission.
Eligible hospitals in china, stratified by economic-geographical regions, will be randomized into either the intervention group or the control group.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack (TIA)
- Being tested
- the Intelligent Lipid Management Decision-support System
- Keywords
- ischemic stroke, LDL-C, LDL-C Target Achievement, the Intelligent Lipid Management Decision-support System, Evolocumab
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Intelligent Lipid Management Decision-support SystemDevice
Doctor's Side: Long-term lipid management support based on guidelines/consensus• Provides lipid management pathways based on guidelines/consensus to ensure clinical decisions align with the latest standards.• Combines individualized patient data to offer intelligent lipid management and medication suggestions.• Provides medical education support to enhance doctors' awareness of guidelines, consensus, and management strategies.Patient's Side: Personalized lipid risk assessment and regular reminders• Based on the lipid test reports uploaded by patients via photos, provides lipid test reports tailored to the patient's risk stratification.• Uses digital tools to regularly remind patients, optimizing follow-up adherence and medication compliance.
| Study group | Role | What they receive |
|---|---|---|
| the Intelligent Lipid Management Decision-support System | Experimental | Doctor's Side: Long-term lipid management support based on guidelines/consensus• Provides lipid management pathways based on guidelines/consensus to ensure clinical decisions align with the latest standards.• Combines individualized patient data to offer intelligent lipid management and medication suggestions.• Provides medical education support to enhance doctors' awareness of guidelines, consensus, and management strategies.Patient's Side: Personalized lipid risk assessment and regular reminders• Based on the lipid test reports uploaded by patients via photos, provides lipid test reports tailored to the patient's risk stratification.• Uses digital tools to regularly remind patients, optimizing follow-up adherence and medication compliance. Receives: Device: the Intelligent Lipid Management Decision-support System |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment
To Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post.
Measured: at 365 days (±14days）
Secondary outcomes (5)
Percentage decrease from baseline in LDL-C at each visit (3 months and 12 months).
To investigate the LDL-C percentage decrease from baseline in patients with ischemic stroke or TIA using Evolocumab at 3 months and 12 months.
Measured: at 90 days (±7 days) and 365 days (±14 days）
Duration (in months) of maintaining LDL-C levels within the target range (<1.8 mmol/L) within 12 months post-intervention.
Duration (in months) of maintaining LDL-C levels within the target range (<1.8 mmol/L) among patients receiving Evolocumab treatment, within 12 months post-intervention.
Measured: at 365 days (±14 days）
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 3 months with Evolocumab treatment
To investigate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients achieving target LDL-C levels at 3 months under Evolocumab treatment with ischemic stroke or TIA in China
Measured: at 90 days（±7 days）
Frequency of subcutaneous Evolocumab injections at 3-month follow-up
Frequency of subcutaneous Evolocumab injections at 3-month follow-up as a measure of treatment persistence in ischemic stroke/TIA patients
Measured: at 90 days （±7 days）
Incidence rate of stroke recurrence and cardiovascular outcome events
Stroke recurrence and cardiovascular outcome events at each visit (3 months and 12 months) following the administration of Evolocumab in patients with ischemic stroke or TIA.
Measured: at 90 days (±7 days) and 365 days (± 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start3 Nov 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Yongjun Wang, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143149
- Sponsor's protocol ID
- KY2025-210 -02
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Intelligent Lipid Management Decision-support System on 1-year LDL-C Target Achievement in Ischemic Stroke or TIA Patients Under Evolocumab Treatment in China
- ClinicalTrials.gov ID
- NCT07143149
- Acronym / sponsor ID
- KY2025-210 -02
- Conditions
- Ischemic Stroke, Transient Ischemic Attack (TIA)
- Keywords
- ischemic stroke, LDL-C, LDL-C Target Achievement, the Intelligent Lipid Management Decision-support System, Evolocumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 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 will conduct a cluster randomized controlled trial to Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.
Detailed description
Large scale randomized trials and systematic reviews have established the efficacy of lipid lowering therapy for acute ischemic stroke. However, adherence to these evidence-based performance measures is suboptimal and gaps in adherence to guideline recommended care are even greater in China. Multifaceted quality improvement interventions that address the barriers to care are effective in changing physician practices. Quality improvement interventions have demonstrated that stroke care quality can be improved by conducting interventions such as using clinical pathways, training physicians on evidence-based guidelines, auditing care delivery, and providing timely feedback.
Aim: To Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.
Intervention: The Intelligent Lipid Management Decision-support System primarily consists of an evidence-based clinical pathway. The evidence-based clinical pathway was written by a panel of stroke experts according to the published statements in peer-reviewed literature, consensus statements and guidelines. It was integrated into the care plan of each eligible stroke admission.
Eligible hospitals in china, stratified by economic-geographical regions, will be randomized into either the intervention group or the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Intelligent Lipid Management Decision-support System | Experimental | Device: the Intelligent Lipid Management Decision-support SystemDoctor's Side: Long-term lipid management support based on guidelines/consensus• Provides lipid management pathways based on guidelines/consensus to ensure clinical decisions align with the latest standards.• Combines individualized patient data to offer intelligent lipid management and medication suggestions.• Provides medical education support to enhance doctors' awareness of guidelines, consensus, and management strategies.Patient's Side: Personalized lipid risk assessment and regular reminders• Based on the lipid test reports uploaded by patients via photos, provides lipid test reports tailored to the patient's risk stratification.• Uses digital tools to regularly remind patients, optimizing follow-up adherence and medication compliance. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years as of the screening date;
- Patients with non-cardioembolic ischemic stroke or TIA within 3 months prior to the screening date;
- Prescribed Evolocumab at physician's discretion;
- Signed informed consent.
Key exclusion criteria (8 listed)
- Intracranial hemorrhagic diseases: such as cerebral hemorrhage, subarachnoid hemorrhage, etc.;
- Patients confirmed by baseline head CT or MRI to have hemorrhage or other pathological brain diseases, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis);
- Silent cerebral infarction without signs and symptoms;
- Participation in a clinical trial of another drug or device in the past 3 months or ongoing at the time of the screening date;
- Any prior use of Evolocumab or other PCSK9 inhibitor treatments within the past 6 months prior to the screening date;
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 |
|---|---|---|
| the Intelligent Lipid Management Decision-support SystemDoctor's Side: Long-term lipid management support based on guidelines/consensus• Provides lipid management pathways based on guidelines/consensus to ensure clinical decisions align with the latest standards.• Combines individualized patient data to offer intelligent lipid management and medication suggestions.• Provides medical education support to enhance doctors' awareness of guidelines, consensus, and management strategies.Patient's Side: Personalized lipid risk assessment and regular reminders• Based on the lipid test reports uploaded by patients via photos, provides lipid test reports tailored to the patient's risk stratification.• Uses digital tools to regularly remind patients, optimizing follow-up adherence and medication compliance. | Device | the Intelligent Lipid Management Decision-support System |
Primary outcome
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment
Time frame: at 365 days (±14days）
To Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post.
5 secondary outcomes
Percentage decrease from baseline in LDL-C at each visit (3 months and 12 months).
Time frame: at 90 days (±7 days) and 365 days (±14 days）
Duration (in months) of maintaining LDL-C levels within the target range (<1.8 mmol/L) within 12 months post-intervention.
Time frame: at 365 days (±14 days）
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 3 months with Evolocumab treatment
Time frame: at 90 days（±7 days）
Frequency of subcutaneous Evolocumab injections at 3-month follow-up
Time frame: at 90 days （±7 days）
Incidence rate of stroke recurrence and cardiovascular outcome events
Time frame: at 90 days (±7 days) and 365 days (± 14 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 2 Jan 2026.
- 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.
Yongjun Wang study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Intelligent Lipid Management Decision-support System in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by Beijing Tiantan Hospital 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 4 inclusion and 8 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 2 Jan 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 Jie Xu (59975672, xujie@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment (time frame: at 365 days (±14days）). 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 2 Jan 2026.