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Clinical application research and evaluation of biomarkers predicting clopidogrel resistance in patients with ischemic stroke

Clinical application research and evaluation of biomarkers predicting clopidogrel resistance in patients with ischemic stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095929
Enrollment
Unknown
Registered
2025-01-15
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Acute ischemic stroke (AIS) and temporary ischemia attack (TIA)

Interventions

Gold Standard:Primary endpoints: Recurrent new stroke (stroke recurrence) within 90 days of antiplatelet therapy, various vascular ischemic events, disability rate, and all-cause mortality. Secondary
2) Compared with before and after, the platelet aggregation rate of clopidogrel was inhibited by less than 20%
3) Platelet aggregation inhibition of clopidogrel is 5 ohms or more (resistance method).
Index test:Plasma C4BP a concentration, CYP2C19 genotyping, mRNA expression levels of mARC1 and ABCC3-013 splice variants.

Sponsors

NanJing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.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); 2.Diagnosed with mild, non cardiogenic, non disabling AIS (NIHSS score = 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: 1.72 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); 2.Patients who require intravenous thrombolysis (using rt PA, urokinase, alteplase, or tiniprase, etc.); 3.Mechanical intervention for thrombectomy; 4.Cardiogenic AIS (with concomitant atrial fibrillation); 5.Embolic stroke of unknown origin (ESUS); 6.Perioperative stroke; 7.Use anticoagulant drugs (such as warfarin, rivaroxaban, dabigatran etexils, etc.); 8.Individuals with severe liver and kidney dysfunction; 9.Individuals allergic to clopidogrel or aspirin; 10.Individuals with a tendency towards bleeding (such as low platelet count or active gastric or intestinal ulcers); 11.Individuals with a history of easy miscarriage or who are currently pregnant; 12.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);Various vascular ischemic events;Disability rate;Death from all causes;

Secondary

MeasureTime frame
Bleeding events;

Countries

China

Contacts

Public ContactXie Hongguang

NanJing First Hospital

hongg.xie@gmail.com+86 25 52887034

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026