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 4

Not yet recruiting

• Conditions: Intracranial Aneurysms; Antiplatelet Drugs
• Interventions: Drug: Aspirin combined with half-dose ticagrelor; Drug: Aspirin combined with clopidogrel

• Registration Number: NCT06486363
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-30
• Status Verified: 2024-07
• Study First Posted: 2024-07-03
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Start: 2024-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin combined with half-dose ticagrelor	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.
Aspirin combined with clopidogrel	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

Primary Outcome Measures

Name	Time	Method
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)
Incidence rate of cerebral stroke	The entire experimental process after endovascular treatment	Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke
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 Outcome Measures

Name	Time	Method
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