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

Phase 4

Recruiting

• Conditions: Ischemic Stroke; Antiplatelet Drug
• Interventions: Drug: Precision Antiplatelet Therapy Trial Group; Drug: Traditional Antiplatelet Therapy Control Group

• Registration Number: NCT06269432
• Lead Sponsor: Sichuan Provincial People's Hospital

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1020

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision Antiplatelet Therapy Trial Group	Precision Antiplatelet Therapy Trial Group	Platelet function testing guides antiplatelet drug selection
Traditional Antiplatelet Therapy Control Group	Traditional Antiplatelet Therapy Control Group	Aspirin 100mg orally once a day

Primary Outcome Measures

Name	Time	Method
The incidence of HOPR at 30 ± 5 days post-enrollment.	1-month	The incidence of HOPR at 30 ± 5days post-enrollment.

Secondary Outcome Measures

Name	Time	Method
The occurrence of major ischemic events and major bleeding events.	3-month	Including cardiovascular and cerebrovascular death, myocardial infarction, stroke, urgent revascularization, in-stent thrombosis, and bleeding events classified as BARC grade 2 or higher.

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China