Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients With Acute Ischemic STROKE
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,138
- 试验地点
- 1
- 主要终点
- Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days
研究概览
简要总结
The objective of this clinical trial is to evaluate the efficacy and safety of platelet aggregation function - guided precision anti - platelet therapy in patients with acute cerebral infarction. The main question it aims to answer is: among the cerebral infarction patients with possible clopidogrel resistance detected by platelet aggregation function tests, what is the efficacy and safety of using ticagrelor to replace the clopidogrel treatment regimen.
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
- None
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
- •Age ≥ 18 years old.
- •Patients diagnosed with acute non-disabling ischaemic stroke or transient ischaemic attack (TIA) with moderate to high stroke risk in accordance with the WHO diagnostic criteria, defined as follows:
- •Acute non-disabling ischaemic stroke: NIHSS score ≤ 5 at enrollment;
- •TIA with moderate to high stroke risk: ABCD₂ score ≥
- •Time from symptom onset ≤ 48 hours. (Definition of symptom onset time: the interval from the last time the patient was observed in a normal state to the time of co-administration of clopidogrel 300 mg and aspirin 100 mg.)
- •MARADP ≥ 35% measured at 5-20 hours after the patient received antiplatelet therapy with co-administration of clopidogrel 300 mg and aspirin 100 mg within 48 hours of symptom onset.
- •Written informed consent signed by the patient or their legal representative.
排除标准
- •Imaging examinations suggestive of hemorrhagic stroke, hemorrhagic transformation, or other pathological cerebral disorders, such as vascular malformation, tumor, abscess, or other common non-ischemic cerebral diseases (e.g., multiple sclerosis).
- •Minor stroke/TIA induced by angioplasty or vascular surgery.
- •Routine electrocardiogram (ECG) suggestive of atrial fibrillation (AF), or physical examination findings of typical AF signs including completely irregular cardiac rhythm, variable intensity of the first heart sound, and pulse deficit.
- •Having definite indications for anticoagulant therapy (suspected cardiogenic embolism, e.g., atrial fibrillation, known artificial heart valve, suspected endocarditis, etc.).
- •Patients who have received intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or any revascularization surgery after the current onset, or plan to receive such procedures within 90 days.
- •Use of antiplatelet agents other than aspirin and clopidogrel (e.g., ticagrelor, prasugrel) within 7 days.
- •History of gastrointestinal bleeding, intracranial hemorrhage, massive hemorrhage or blood transfusion in the recent period (excluding mild hemoptysis and mild abnormal vaginal bleeding), or history of other hemorrhagic diseases caused by coagulation dysfunction (e.g., purpura).
- •Having contraindications to or intolerance of clopidogrel, ticagrelor, or aspirin, including:
- •Known history of hypersensitivity;
- •Severe hepatic or renal insufficiency (definition of severe hepatic insufficiency: ALT > 2× upper limit of normal [ULN] or AST > 2× ULN; definition of severe renal insufficiency: creatinine > 1.5× ULN);
- •Severe heart failure (NYHA Class Ⅲ or Ⅳ);
- •Coagulation disorders or history of systemic hemorrhage;
- •History of previous thrombocytopenia or neutropenia;
- •History of previous drug-induced hematological diseases or hepatic dysfunction.
- •Leukopenia (< 2×10⁹/L) or thrombocytopenia (< 100×10⁹/L).
- •Use of heparin or oral anticoagulants within 10 days prior to enrollment.
- •Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency, and those with severe comorbidities (e.g., malignancy, chronic airflow limitation, severe dementia, severe heart failure).
- •Women of childbearing age with a negative pregnancy test but who refuse to adopt effective contraceptive measures; pregnant or lactating women.
- •Poor compliance, unable to cooperate with the requirements of the study.
研究组 & 干预措施
The ticagrelor
Ticagrelor 90 mg should be administered as early as possible (within 12-24 hours after the loading dose).
From Day 1 to Day 21 after enrollment: Patients shall receive dual antiplatelet therapy with oral ticagrelor 90 mg bid and aspirin 100 mg qd.
From Day 22 to Day 90 after enrollment: Patients shall receive monotherapy with oral ticagrelor 90 mg bid.
干预措施: The ticagrelor (Drug)
The Clopidogrel
From the 1st to the 21st day, the patient should receive dual anti - platelet therapy with clopidogrel 75mg once a day (qd) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given clopidogrel 75mg qd for anti - platelet treatment.
干预措施: The Clopidogrel (Drug)
结局指标
主要结局
Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days
时间窗: within 90 days
次要结局
- Recurrent ischemic stroke(On the 7th day, at 30 days, and within 1 year)
- New-onset vascular events(On the 7th day, at 30 days, at 90 days and within 1 year.)
- Modified Rankin Scale (mRS) score(at 30 days, 90 days, and 1 year)
- Recurrent stroke(On the 7th day, the 30th day, the 90th day and within one year.)
- Worsening of nerve damage (an increase in the NIHSS score by ≥ 4 points compared to the baseline)(At the 24th hour and on the 7th day)
- Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire](at 90 days)
研究者
Jie Yang
Deputy Director of the Department of Neurology
Sichuan Provincial People's Hospital