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

Обзор

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

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Incidence rate of cerebral stroke [Срок оценки: The entire experimental process after endovascular treatment]
• Modified Rankin Scale [Срок оценки: 6 months after endovascular surgery]
• Mini-mental state examination [Срок оценки: 6 months after endovascular surgery]

Вторичные конечные точки (1)

• Platelet inhibition rate/platelet aggregation rate [Срок оценки: 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06486363 · 2023-536-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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