Clinical trial

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

Name
2023-536-02
Description
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
Trial arms
Trial start
2024-07-01
Estimated PCD
2026-07-31
Trial end
2027-07-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
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
Arms:
Aspirin combined with clopidogrel
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
Arms:
Aspirin combined with half-dose ticagrelor
Size
196
Primary endpoint
Platelet inhibition rate/platelet aggregation rate
1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery
Eligibility criteria
Inclusion Criteria: 1. Patients with unruptured intracranial aneurysms who are scheduled for stent-assisted embolization; 2. mRS score less than or equal to 2 on admission; 3. Normal CYP2C19 metabolizer genotype; 4. Age 20 or above, 70 or below, regardless of gender; 5. The subject or the entrusted family member voluntarily signed the informed consent for this trial Exclusion Criteria: 1. Use of drugs that affect coagulation function or significant abnormalities in platelet/coagulation function before admission; 2. Previous history of cardiovascular and cerebrovascular disease; 3. Complications of major organ dysfunction, chronic inflammatory diseases or malignant tumors at admission; 4. Known allergy or contraindication to heparin, aspirin, clopidogrel, or ticagrelor; 5. Patients with any severe or active pathological bleeding; 6. Pregnant and lactating female; 7. Those deemed unsuitable to participate in this trial by the responsible physician
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 196, 'type': 'ESTIMATED'}}
Updated at
2024-07-03

1 organization

2 products

2 indications