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

Not yet recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT07028775
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-21
• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 839

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
In-stent restenosis	At 90 days after antiplatelet therapy	Head-neck CTA

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China