Biomarkers of Clopidogrel Resistance for Predicting Ischemic Recurrence 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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Recurrent ischemic stroke

Time frame: 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 outcomes

In-stent restenosis

Time frame: At 90 days after antiplatelet therapy

Head-neck CTA

Other outcomes

ADP-induced platelet aggregation

Time frame: At 72 hours and 30 days after antiplatelet therapy

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Tai, Doctor

CONTACT

[email protected]

86 25 52887003

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jun 19, 2025
Registry last updated: Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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