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Evaluation of the Efficacy of Novel Biomarkers in Predicting Clopidogrel Resistance in Patients with Ischemic Stroke

Clinical Application Research and Evaluation of Biomarkers Predicting Clopidogrel Resistance in Patients with Ischemic Stroke

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06753149
Enrollment
800
Registered
2024-12-31
Start date
2025-02-01
Completion date
2026-03-31
Last updated
2024-12-31

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

Conditions

Clopidogrel Resistance, Ischemic Stroke, TIA (Transient Ischemic Attack)

Brief summary

The goal of this observational study is to explore the potential efficacy of related biomakers in predicting clopidogrel resistance in patients with ischemic stroke. To be specific : 1. To investigate the relationship between the changes in ADP induced platelet aggregation rate, human plasma C4BPα concentration, mRNA expression levels of mARC1 and ABCC3-013 (splicing variant) in peripheral blood leukocytes, and the changes in the mRNA expression levels of ABCC3-013 (splicing variant) in selected hospitalized patients before and on the 3rd and 7th day after antiplatelet therapy, as well as on the 30th and 90th day after follow-up, in accordance with the current guidelines for secondary stroke prevention, and to explore the relative efficacy of each biomarker in predicting clopidogrel resistance; 2. To collect blood samples from patients, extract their DNA samples, perform CYP2C19 genotyping, validate and evaluate the predictive efficacy and clinical application value of a biomarker panel composed of multiple new and old biomarkers for predicting clopidogrel resistance.

Interventions

None listed

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age range: 18-80 years old. Within 72 hours after symptom onset (admission), the patient has started receiving standard antiplatelet therapy (which must include Plavix, taken alone or in combination) * Diagnosed with mild, non cardiogenic, non disabling AIS (NIHSS score ≤ 3) or high-risk TIA (ABCD2 stroke risk assessment ≥ 4) based on the patient's symptoms, signs (such as hemiplegia, hemianopia, hemiparesis, aphasia, etc.) and various routine diagnoses and tests (including but not limited to neuroimaging, such as cranial CT, MRI, Doppler, etc.)

Exclusion criteria

* 72 hours after the onset of symptoms (admission), the patient began receiving standard antiplatelet therapy (including polivix, taken alone or in combination) for moderate or severe AIS (NIHSS score ≥ 5) * Patients who require intravenous thrombolysis (using rt PA, urokinase, alteplase, or tiniprase, etc.) * Mechanical intervention for thrombectomy * Cardiogenic AIS (with concomitant atrial fibrillation) * Embolic stroke of unknown origin (ESUS) * Perioperative stroke * Use anticoagulant drugs (such as warfarin, rivaroxaban, dabigatran etexils, etc.) * Individuals with severe liver and kidney dysfunction * Individuals allergic to clopidogrel or aspirin * Individuals with a tendency towards bleeding (such as low platelet count or active gastric or intestinal ulcers) * Individuals with a history of easy miscarriage or who are currently pregnant * Patients with malignant tumors or life expectancy of less than 1 year

Design outcomes

Primary

MeasureTime frame
Recurrent new stroke within 90 days after antiplatelet therapy (stroke recurrence)From enrollment to the end of treatment at 90 days

Contacts

Primary ContactHong-Guang Xie, Professor
hongg.xie@gmail.com086-025-52887034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026