Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Ischemic STROKE
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- The incidence of HOPR at 30 ± 5 days post-enrollment.
研究概览
简要总结
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 80 years;
- •Diagnosed with non-cardiogenic ischemic stroke according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.;
- •First stroke onset ≥ 1 month and ≤ 3 months;
- •mRS Score <=2 points;
- •Undergoing antiplatelet therapy with 100mg aspirin daily for at least 8 days;
- •Informed consent signed by the patient or their family member.
排除标准
- •History of recurrent stroke.
- •History of gastrointestinal bleeding, intracranial hemorrhage, or other bleeding disorders.
- •Contraindications or intolerance to antiplatelet therapy medications.
- •Severe cardiac, pulmonary, hepatic, or renal insufficiency, or presence of severe comorbid conditions (e.g., end-stage malignant tumors, severe single/multiple organ failure).
- •Poor compliance, inability to cooperate with study requirements.
研究组 & 干预措施
Precision Antiplatelet Therapy Trial Group
Platelet function testing guides antiplatelet drug selection
干预措施: Precision Antiplatelet Therapy Trial Group (Drug)
Traditional Antiplatelet Therapy Control Group
Aspirin 100mg orally once a day
干预措施: Traditional Antiplatelet Therapy Control Group (Drug)
结局指标
主要结局
The incidence of HOPR at 30 ± 5 days post-enrollment.
时间窗: 1-month
The incidence of HOPR at 30 ± 5days post-enrollment.
次要结局
- The occurrence of major ischemic events and major bleeding events.(3-month)
研究者
Jie Yang
Deputy Director of the Institute of Neurology
Sichuan Provincial People's Hospital