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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07028775

Enrollment

839

Registered

2025-06-19

Start date

2025-06-30

Completion date

2027-04-30

Last updated

2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Ischemic stroke, Cerebral artery stenting, Clopidogrel resistance, Biomarkers

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Other

Measure	Time frame	Description
ADP-induced platelet aggregation	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.

Countries

China

Contacts

Primary ContactTing Tai, Doctor

taiting67003@163.com86 25 52887003

Outcome results