An interventional study of the Intelligent Lipid Management Decision-support System in Ischemic Stroke and Transient Ischemic Attack (TIA), sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention
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.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: the Intelligent Lipid Management Decision-support System
Usual Care
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.
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.
Time frame: at 365 days (±14days）
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.
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.
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.
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
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
Time frame: 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
Time frame: 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.
Time frame: at 90 days (±7 days) and 365 days (± 14 days)
Plan to share: No
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