Intelligent lipid-management system to help stroke or TIA patients on evolocumab reach one-year LDL-C targets

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

We will test whether an intelligent lipid-management decision-support system helps adults in China with ischemic stroke or TIA who are taking evolocumab reach LDL-C under 1.8 mmol/L after one year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 4000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Drugs / interventions: Evolocumab
• Locations: 1 site (Beijing)
• Trial ID: NCT07143149 on ClinicalTrials.gov

What this trial studies

This cluster randomized controlled trial randomizes eligible hospitals across China to add an evidence-based intelligent lipid management decision-support pathway to routine care or to continue usual care. The pathway, developed by stroke experts from guidelines and the literature, is integrated into the care plan for eligible admissions and applied to patients prescribed evolocumab after non-cardioembolic ischemic stroke or TIA. The primary outcome is the proportion of patients achieving LDL‑C <1.8 mmol/L at one year post-intervention. Hospitals are stratified by economic-geographic region and patients are followed for 12 months to compare LDL‑C target achievement between groups.

Who should consider this trial

Good fit: Adults (≥18) in China with recent non-cardioembolic ischemic stroke or TIA (within 3 months) who are prescribed evolocumab and can provide informed consent.

Not a fit: Patients with hemorrhagic brain disease, silent cerebral infarction, recent or prior PCSK9 inhibitor use within 6 months, concurrent participation in another drug/device trial, or life expectancy under 12 months are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, more patients could reach LDL‑C targets, which may reduce the risk of recurrent vascular events after stroke or TIA.

How similar studies have performed: Large randomized trials have shown lipid-lowering reduces stroke risk and quality-improvement interventions can improve guideline adherence, but embedding an intelligent decision-support system specifically for evolocumab-treated stroke patients is a relatively new approach.

Eligibility criteria

Inclusion Criteria

1. Age≥18 years as of the screening date;
2. Patients with non-cardioembolic ischemic stroke or TIA within 3 months prior to the screening date;
3. Prescribed Evolocumab at physician's discretion;
4. Signed informed consent.

Exclusion Criteria:

1. Intracranial hemorrhagic diseases: such as cerebral hemorrhage, subarachnoid hemorrhage, etc.;
2. 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);
3. Silent cerebral infarction without signs and symptoms;
4. Participation in a clinical trial of another drug or device in the past 3 months or ongoing at the time of the screening date;
5. Any prior use of Evolocumab or other PCSK9 inhibitor treatments within the past 6 months prior to the screening date;
6. Life expectancy \<12 months or unable to complete the research for other reasons as of the screening date;
7. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders;
8. Refusal to participate in the enrollment survey.

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jie Xu

Conditions Ischemic Stroke; Transient Ischemic Attack; ischemic stroke; LDL-C; LDL-C Target Achievement; the Intelligent Lipid Management Decision-support System; Evolocumab