Clinical trial NCT06486363: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Intracranial Aneurysms
Antiplatelet Drugs
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 196
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence rate of cerebral stroke
timeFrame: The entire experimental process after endovascular treatment
measure: Modified Rankin Scale
timeFrame: 6 months after endovascular surgery
measure: Mini-mental state examination
timeFrame: 6 months after endovascular surgery
Secondary outcomes:
measure: Platelet inhibition rate/platelet aggregation rate
timeFrame: 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing university
name: Shijie Na, Doctor
role: PRINCIPAL_INVESTIGATOR
References: