NCT07143149

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-11-03
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-08-27
• Last updated: 2026-01-02

Locations

1 site across 1 country: China