Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Ischemic STROKE（PATH-STROKE）

Sichuan Provincial People's Hospital

Status and phase: Enrolling; Phase 4

Conditions: Ischemic Stroke; Antiplatelet Drug

Treatments: Drug: Traditional Antiplatelet Therapy Control Group; Drug: Precision Antiplatelet Therapy Trial Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06269432

2023YFS0042

Details and patient eligibility

About

1. Main objective: To explore the efficacy of precise antiplatelet therapy guided by platelet aggregation function in reducing the incidence of 30 day platelet hyperresponsiveness in patients with non-cardiogenic ischemic stroke.
2. Secondary objective: To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic ischemic stroke under the guidance of platelet aggregation function.

Full description

Non cardiac cerebral infarction accounts for more than 50% of cerebral infarction cases, and the key to its onset is increased platelet aggregation function. Aspirin and clopidogrel are Class A recommended drugs for the prevention and treatment of non cardiac cerebral infarction. However, after regular use of aspirin and clopidogrel, more than 30% of stroke patients still experience high on treatment platelet reactivity (HOPR) due to aspirin resistance and clopidogrel resistance, leading to stroke recurrence. Antiplatelet therapy is the cornerstone of the prevention and treatment of non cardiogenic cerebral infarction. Therefore, clinical research on the prevention and treatment of HOPR with antiplatelet therapy for non cardiogenic cerebral infarction is of great significance, which can help partially solve the bottleneck of resistance to antiplatelet therapy in cerebral infarction.Platelet aggregation function testing can timely detect antiplatelet therapy HOPR, guide drug adjustment, and is expected to become a testing standard for the prevention and treatment of antiplatelet therapy resistance.

Enrollment: 1,020 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged from 18 to 80 years;
2. Diagnosed with non-cardiogenic ischemic stroke according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.;
3. First stroke onset ≥ 1 month and ≤ 3 months;
4. mRS Score <=2 points;
5. Undergoing antiplatelet therapy with 100mg aspirin daily for at least 8 days;
6. Informed consent signed by the patient or their family member.

Exclusion criteria

1. History of recurrent stroke.
2. History of gastrointestinal bleeding, intracranial hemorrhage, or other bleeding disorders.
3. Contraindications or intolerance to antiplatelet therapy medications.
4. Severe cardiac, pulmonary, hepatic, or renal insufficiency, or presence of severe comorbid conditions (e.g., end-stage malignant tumors, severe single/multiple organ failure).
5. Poor compliance, inability to cooperate with study requirements.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,020 participants in 2 patient groups

Precision Antiplatelet Therapy Trial Group

Experimental group

Description:

Platelet function testing guides antiplatelet drug selection

Treatment:

Drug: Precision Antiplatelet Therapy Trial Group

Traditional Antiplatelet Therapy Control Group

Active Comparator group

Description:

Aspirin 100mg orally once a day

Treatment:

Drug: Traditional Antiplatelet Therapy Control Group