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Not yet recruiting NCT07028775

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

Observational Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Recurrent ischemic stroke [Time frame: At 30 days, 90 days, 6 months, and 1 year after antiplatelet therapy]
Secondary outcome measures (1)
  • In-stent restenosis [Time frame: At 90 days after antiplatelet therapy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Nanjing First Hospital — Nanjing

Identifiers

NCT: NCT07028775 · KY20250425-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗