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NCT Number: NCT06753149

Evaluation of the Efficacy of Novel Biomarkers in 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrent new stroke within 90 days after antiplatelet therapy (stroke recurrence)

    Time frame: From enrollment to the end of treatment at 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Hong-Guang Xie, Professor

CONTACT

[email protected]

086-025-52887034

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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