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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Tiantan Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jie Xu
• Email: xujie@ncrcnd.org.cn
• Phone: 59975672

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.