NCT07028775

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
839

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jun 2025Apr 2027

First Submitted

Initial submission to the registry

May 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

May 21, 2025

Last Update Submit

June 11, 2025

Conditions

Ischemic Stroke

Keywords

Ischemic strokeCerebral artery stentingClopidogrel resistanceBiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • In-stent restenosis

    At 90 days after antiplatelet therapy

Other Outcomes (1)

  • ADP-induced platelet aggregation

    At 72 hours and 30 days after antiplatelet therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ting Tai, Doctor

CONTACT

86 25 52887003taiting67003@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 19, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)