Comparison of the Antiplatelet Efficacy of Aspirin Combined With Clopidogrel and Aspirin Combined With Half-dose Ticagrelor in Patients With Unruptured Intracranial Aneurysms With Normal CYP2C19 Metabolizer Phenotype
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 196
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. The main questions it aims to answer are:
If aspirin combined with half-dose ticagrelor is comparable to or better than aspirin combined with clopidogrel? What medical problems do participants have when taking aspirin combined with half-dose ticagrelor? Researchers will compare aspirin combined with half-dose ticagrelor to aspirin combined with clopidogrel to see if aspirin combined with half-dose ticagrelor works to treat patients with unruptured intracranial aneurysms received endovascular treatment.
Participants will:
Take aspirin combined with half-dose ticagrelor or aspirin combined with clopidogrel every day for 6 months Visit the clinic 1 month and 6 months for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unruptured intracranial aneurysms who are scheduled for stent-assisted embolization;
- •mRS score less than or equal to 2 on admission;
- •Normal CYP2C19 metabolizer genotype;
- •Age 20 or above, 70 or below, regardless of gender;
- •The subject or the entrusted family member voluntarily signed the informed consent for this trial
排除标准
- •Use of drugs that affect coagulation function or significant abnormalities in platelet/coagulation function before admission;
- •Previous history of cardiovascular and cerebrovascular disease;
- •Complications of major organ dysfunction, chronic inflammatory diseases or malignant tumors at admission;
- •Known allergy or contraindication to heparin, aspirin, clopidogrel, or ticagrelor;
- •Patients with any severe or active pathological bleeding;
- •Pregnant and lactating female;
- •Those deemed unsuitable to participate in this trial by the responsible physician
研究组 & 干预措施
Aspirin combined with clopidogrel
Participants in this group shall take Aspirin (100 mg/day) + clopidogrel (75 mg/day) for at least 5 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment
干预措施: Aspirin combined with clopidogrel (Drug)
Aspirin combined with half-dose ticagrelor
Participants in this group shall take Aspirin (100 mg/day) + half dose of ticagrelor (45 mg, 12 hours/time), at least for 3 days before receiving stent-assisted coil embolization, and take same medication for 6 months after endovascular treatment.
干预措施: Aspirin combined with half-dose ticagrelor (Drug)
结局指标
主要结局
Modified Rankin Scale
时间窗: 6 months after endovascular surgery
Modified Rankin Scale ( The scale runs from 0 to 6, 0 means perfect health and 6 means death)
Incidence rate of cerebral stroke
时间窗: The entire experimental process after endovascular treatment
Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke
Mini-mental state examination
时间窗: 6 months after endovascular surgery
The MMSE examination includes time and place orientation, registration, attention and calculation, recall, language, repitition, complex commands. Score excess 24 or more indicates a normal cognition, 19-23 points indicates mild cognitive impairment, score of 10-18 points indicates moderate cognitive impairment and score below 9 points indicates severe cognitive impairment
次要结局
- Platelet inhibition rate/platelet aggregation rate(1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery)
研究者
Shijie Na
Deputy chief physician of Neurosurgery, Principal Investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School