NCT06753149Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Stroke
- NCT number
- NCT06753149
What you commit to
- Study type: Observational
- Planned participants: 800
- From 1 Feb 2025 to the primary completion date, 31 Mar 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Cardiogenic AIS (with concomitant atrial fibrillation)
- Use anticoagulant drugs (such as warfarin, rivaroxaban, dabigatran etexils, etc.)
Other illness
- Embolic stroke of unknown origin (ESUS)
- Perioperative stroke
- Individuals allergic to clopidogrel or aspirin
- Individuals with a history of easy miscarriage or who are currently pregnant
- Patients with malignant tumors or life expectancy of less than 1 year
Lab values
- Individuals with a tendency towards bleeding (such as low platelet count or active gastric or intestinal ulcers)
Other
- Patients who require intravenous thrombolysis (using rt PA, urokinase, alteplase, or tiniprase, etc.)
- Mechanical intervention for thrombectomy
- Individuals with severe liver and kidney dysfunction
Who the study is looking for
- 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.)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.