Antiplatelet Drugs, Intracranial Aneurysms
Conditions
Brief summary
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
Interventions
DRUGAspirin 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
DRUGAspirin 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
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of cerebral stroke | The entire experimental process after endovascular treatment | Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke |
| Modified Rankin Scale | 6 months after endovascular surgery | Modified Rankin Scale ( The scale runs from 0 to 6, 0 means perfect health and 6 means death) |
| Mini-mental state examination | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet inhibition rate/platelet aggregation rate | 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery | Platelet inhibition rate/platelet aggregation rate |
Contacts
Primary ContactZong Zhuang, Doctor
Outcome results
None listed