Clinical Application Study and Evaluation of Clopidogrel Resistance-Related Biomarkers in Predicting the Recurrence of Ischemic Events After Cerebral Artery Stenting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 839
- 试验地点
- 1
- 主要终点
- Recurrent ischemic stroke
研究概览
简要总结
This study aims to evaluate the clinical significance of clopidogrel resistance-associated biomarkers (TMAO, C1q, and C4BPα) in patients receiving cerebral artery stents, and to develop an integrated predictive model incorporating these novel biomarkers along with CYP2C19 genotyping data for accurate clopidogrel resistance prediction in Chinese populations. By establishing this multidimensional assessment system, we intend to provide reliable risk stratification for post-stenting ischemic events and in-stent restenosis, ultimately facilitating personalized antiplatelet therapy decisions in cerebrovascular interventions. The proposed model may serve as a valuable clinical tool to optimize treatment strategies and improve outcomes for stented patients at risk of clopidogrel resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, with ischemic stroke due to atherosclerotic cerebrovascular stenosis;
- •Scheduled for cerebral artery stenting with standard dual antiplatelet therapy (aspirin 100 mg/day + clopidogrel 75 mg/day) for ≥3 months.
排除标准
- •Cardioembolic stroke (e.g., with atrial fibrillation);
- •Embolic stroke of undetermined source (ESUS);
- •Perioperative stroke;
- •Requiring intravenous thrombolysis (rt-PA, urokinase, alteplase, or tenecteplase);
- •Mechanical thrombectomy;
- •Current use of anticoagulants (warfarin, rivaroxaban, dabigatran, etc.);
- •Severe hepatic or renal dysfunction;
- •Allergy to clopidogrel or aspirin;
- •Bleeding tendency (e.g., thrombocytopenia or active gastrointestinal ulcer);
- •History of recurrent miscarriage or current pregnancy;
- •Malignancy or life expectancy <1 year.
结局指标
主要结局
Recurrent ischemic stroke
时间窗: At 30 days, 90 days, 6 months, and 1 year after antiplatelet therapy
Recurrent ischemic stroke is defined as either: 1) acute exacerbation of pre-existing deficits occurring ≥21 days post-initial event onset, or 2) emergence of novel neurological deficits (including transient ischemic attack and acute ischemic stroke). Diagnostic confirmation requires both clinical correlation with symptoms and neuroimaging evidence (MRI) demonstrating new cerebral infarction within the original vascular territory, or acute neurological symptoms (within 24 hours) localizing to the original vascular territory with absence of new cerebral infarction on MRI.
次要结局
- In-stent restenosis(At 90 days after antiplatelet therapy)