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

Clinical Application Study and Evaluation of Clopidogrel Resistance-Related Biomarkers in Predicting the Recurrence of Ischemic Events After Cerebral Artery Stenting

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke

• Study Type: Observational
• Enrollment (Estimated): 839

Contacts and Locations

• Study Contact: Name: Ting Tai, Doctor; Phone Number: 86 25 52887003; Email: taiting67003@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants will be enrolled from the inpatient department of neurology at Nanjing First Hospital.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent ischemic stroke	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.	At 30 days, 90 days, 6 months, and 1 year after antiplatelet therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent restenosis	Head-neck CTA	At 90 days after antiplatelet therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADP-induced platelet aggregation	Whole blood platelet aggregation induced by ADP was detected by a whole-blood aggregometer (Chrono-Log model 590-2D, Chromo-Log Corp., Havertown, PA, USA). Changes in electronic resistance (Ω) values between two electrodes were recorded to reflect the rate of whole-blood platelet aggregation.	At 72 hours and 30 days after antiplatelet therapy

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: June 11, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Biomarkers; Ischemic stroke; Clopidogrel resistance; Cerebral artery stenting
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Stroke; Ischemic Stroke; Ischemia; Recurrence
• Other Study ID Numbers: KY20250425-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No