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

NCT ID: NCT07143149

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2028-03-31

Brief 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 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.

Conditions

Ischemic Stroke; Transient Ischemic Attack (TIA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

the Intelligent Lipid Management Decision-support System

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.

Group Type: EXPERIMENTAL

the Intelligent Lipid Management Decision-support System

Intervention Type: DEVICE

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.

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

the Intelligent Lipid Management Decision-support System

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongjun Wang

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Xu

Role: CONTACT

xujie@ncrcnd.org.cn

59975672

Aichun Cheng

Role: CONTACT

aichuncheng0822@163.com

13240768490

Facility Contacts

Jie Xu

Role: primary

xujie@ncrcnd.org.cn

59978555 ext. 59975672

Other Identifiers

KY2025-210 -02

Identifier Type: -

Identifier Source: org_study_id