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

Beijing Tiantan Hospital4,000 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Interventions

the Intelligent Lipid Management Decision-support SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment

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.

Time frame: at 365 days (±14days）

Secondary Outcomes

Percentage decrease from baseline in LDL-C at each visit (3 months and 12 months).

To investigate the LDL-C percentage decrease from baseline in patients with ischemic stroke or TIA using Evolocumab at 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.

Duration (in months) of maintaining LDL-C levels within the target range (\<1.8 mmol/L) among patients receiving Evolocumab treatment, 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

To investigate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients achieving target LDL-C levels at 3 months under Evolocumab treatment with ischemic stroke or TIA in China

Time frame: at 90 days（±7 days）

Frequency of subcutaneous Evolocumab injections at 3-month follow-up

Frequency of subcutaneous Evolocumab injections at 3-month follow-up as a measure of treatment persistence in ischemic stroke/TIA patients

Time frame: at 90 days （±7 days）

Incidence rate of stroke recurrence and cardiovascular outcome events

Stroke recurrence and cardiovascular outcome events at each visit (3 months and 12 months) following the administration of Evolocumab in patients with ischemic stroke or TIA.

Time frame: at 90 days (±7 days) and 365 days (± 14 days)