Nanjing First Hospital, Nanjing Medical University
Phase
Observational
Started
2025-06
Last updated
2025-06-19
Condition(s) studied
Ischemic Stroke
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Recurrent ischemic stroke — 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.
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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