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

Nanjing University

Status and phase: Not yet enrolling; Phase 4

Conditions: Intracranial Aneurysms; Antiplatelet Drugs

Treatments: Drug: Aspirin combined with clopidogrel; Drug: Aspirin combined with half-dose ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT06486363

2023-536-02

Details and patient eligibility

About

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

Enrollment: 196 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Aspirin combined with clopidogrel

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin combined with clopidogrel

Aspirin combined with half-dose ticagrelor

Experimental group

Description:

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.

Treatment:

Drug: Aspirin combined with half-dose ticagrelor