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

NCT07143149 | Recruiting DMC

• 1 other identifier: KY2025-210 -02
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack (TIA)

Keywords

ischemic stroke; LDL-C; LDL-C Target Achievement; the Intelligent Lipid Management Decision-support System; Evolocumab

Outcome Measures

Primary Outcomes (1)

• 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.

  at 365 days (±14days）

Secondary Outcomes (5)

• 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）

• 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）

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

  at 90 days （±7 days）

• Incidence rate of stroke recurrence and cardiovascular outcome events

  at 90 days (±7 days) and 365 days (± 14 days)

Study Arms (2)

the Intelligent Lipid Management Decision-support System

EXPERIMENTAL

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.

Device: the Intelligent Lipid Management Decision-support System

Usual Care

NO INTERVENTION

Usual Care

Interventions

the Intelligent Lipid Management Decision-support System 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.

the Intelligent Lipid Management Decision-support System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Yongjun Wang

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Jie Xu

CONTACT

59975672; xujie@ncrcnd.org.cn

Aichun Cheng

CONTACT

13240768490; aichuncheng0822@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 27, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)