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

NCT ID: NCT06486363

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-07-31

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

Conditions

Intracranial Aneurysms; Antiplatelet Drugs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Aspirin combined with clopidogrel

Intervention Type: DRUG

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 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.

Group Type: EXPERIMENTAL

Aspirin combined with half-dose ticagrelor

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Shijie Na

Deputy chief physician of Neurosurgery, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shijie Na, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing university

Central Contacts

Zong Zhuang, Doctor

Role: CONTACT

zhuangzong@126.com

+86 15850560410

Other Identifiers

2023-536-02

Identifier Type: -

Identifier Source: org_study_id