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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; TIA (Transient Ischemic Attack); Clopidogrel Resistance

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Hong-Guang Xie, Professor; Phone Number: 086-025-52887034; Email: hongg.xie@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• 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.)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Clopidogrel resistance; Definition of clopidogrel resistance (quantitative indicator): After patients take clopidogrel: The maximum platelet aggregation rate (%) value is greater than 50%;; Compared before and after, clopidogrel inhibits platelet aggregation by less than 20%;; The platelet aggregation inhibition of clopidogrel is 5 ohms or more (resistance method).
Clopidogrel sensitivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrent new stroke within 90 days after antiplatelet therapy (stroke recurrence)	From enrollment to the end of treatment at 90 days

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemic Attack, Transient; Ischemia
• Other Study ID Numbers: KY20241217-06

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.: Yes