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

Phase 4RecruitingNCT06269432

Sichuan Provincial People's Hospital1,020 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,020

Conditions

Interventions

Precision Antiplatelet Therapy Trial GroupDRUG

Use SPCM method to detect platelet aggregation function in patients, adjust antiplatelet drugs based on the test results, and receive precise antiplatelet treatment for 12 months. Non resistant patients with aspirin will continue to receive aspirin 100mg qd; Patients with aspirin resistance were given clopidogrel 75mg qd; Clopidogrel resistant patients were given ticagrelor 90mg bid.

Traditional Antiplatelet Therapy Control GroupDRUG

No adjustment of antiplatelet medication is required, and routine treatment with aspirin 100mg qd is given for 12 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The incidence of HOPR at 30 ± 5 days post-enrollment.

The incidence of HOPR at 30 ± 5days post-enrollment.

Time frame: 1-month

Secondary Outcomes

The occurrence of major ischemic events and major bleeding events.

Including cardiovascular and cerebrovascular death, myocardial infarction, stroke, urgent revascularization, in-stent thrombosis, and bleeding events classified as BARC grade 2 or higher.

Time frame: 3-month