Biomarkers of Clopidogrel Resistance for Predicting Ischemic Recurrence After Cerebral Artery Stenting

Nanjing Medical University

Status: Not yet enrolling

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT07028775

KY20250425-08

Details and patient eligibility

About

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.

Enrollment: 839 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.