ClinicalTrials.gg
Not yet recruitingNCT06753149Updated Dec 31, 2024

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

An observational study in Ischemic Stroke, TIA (Transient Ischemic Attack) and Clopidogrel Resistance, sponsored by Nanjing First Hospital, Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 80 Years
Sex
All
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Study 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.
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Conditions studied

  • Ischemic Stroke
  • TIA (Transient Ischemic Attack)
  • Clopidogrel Resistance
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In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 800 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 224 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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 count or active gastric or intestinal ulcers)
  • Individuals with a history of easy miscarriage or who are currently pregnant
  • Patients with malignant tumors or of less than 1 year
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Clopidogrel resistance

    Definition of clopidogrel resistance (quantitative indicator): After patients take clopidogrel: 1. The maximum platelet aggregation rate (%) value is greater than 50%; 2. Compared before and after, clopidogrel inhibits platelet aggregation by less than 20%; 3. The platelet aggregation inhibition of clopidogrel is 5 ohms or more (resistance method).

  • Clopidogrel sensitivity
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What researchers measure

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

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06753149
Responsible party
Sponsor
First posted
Dec 31, 2024
Start date
Feb 1, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Dec 31, 2024

Study contacts

Hong-Guang Xie, Professor
Contact
hongg.xie@gmail.com
086-025-52887034

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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