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

June 11, 2025 updated by: Nanjing First Hospital, Nanjing Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
839

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 30 days, 90 days, 6 months, and 1 year after antiplatelet therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-stent restenosis
Time Frame: At 90 days after antiplatelet therapy
Head-neck CTA
At 90 days after antiplatelet therapy

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At 72 hours and 30 days after antiplatelet therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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