Clinical trial NCT06269432: Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE（PATH-STROKE）
Official title: Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Antiplatelet Drug
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 1020
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of HOPR at 30 ± 5 days post-enrollment.
timeFrame: 1-month
Secondary outcomes:
measure: The occurrence of major ischemic events and major bleeding events.
timeFrame: 3-month
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Jie Yang, doctor
role: STUDY_CHAIR
affiliation: First Affiliated Hospital of Chengdu Medical College
name: YaPeng Lin
role: STUDY_CHAIR
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