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

Phase 4Not Yet RecruitingNCT06486363

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School196 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

196

Conditions

Intracranial Aneurysms Antiplatelet Drugs

Interventions

Aspirin combined with clopidogrelDRUG

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

Aspirin combined with half-dose ticagrelorDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence rate of cerebral stroke

Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke

Time frame: The entire experimental process after endovascular treatment

Modified Rankin Scale

Modified Rankin Scale ( The scale runs from 0 to 6, 0 means perfect health and 6 means death)

Time frame: 6 months after endovascular surgery

Mini-mental state examination

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

Time frame: 6 months after endovascular surgery

Secondary Outcomes

Platelet inhibition rate/platelet aggregation rate

Time frame: 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery