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

Overview

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.

Interventions

• 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 reminde

Primary outcome measures

• Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment [Time frame: at 365 days (±14days）]

Secondary outcome measures (5)

• Percentage decrease from baseline in LDL-C at each visit (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. [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 [Time frame: at 90 days（±7 days）]
• Frequency of subcutaneous Evolocumab injections at 3-month follow-up [Time frame: at 90 days （±7 days）]
• Incidence rate of stroke recurrence and cardiovascular outcome events [Time frame: at 90 days (±7 days) and 365 days (± 14 days)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT07143149 · KY2025-210 -02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗