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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment
时间窗: at 365 days (±14days）
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.
次要结局
- Percentage decrease from baseline in LDL-C at each visit (3 months and 12 months).(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.(at 365 days (±14 days）)
- Frequency of subcutaneous Evolocumab injections at 3-month follow-up(at 90 days （±7 days）)
- Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 3 months with Evolocumab treatment(at 90 days（±7 days）)
- Incidence rate of stroke recurrence and cardiovascular outcome events(at 90 days (±7 days) and 365 days (± 14 days))
研究者
Yongjun Wang
professor
Beijing Tiantan Hospital