Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms (GATITIA)

Capital Medical University

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Drug: Adjustment of Antiplatelet Drugs

Study type: Interventional

Funder types: Other

Identifiers

NCT05825391

Xinjian Yang

Details and patient eligibility

About

The use of intracranial stents expands the possibilities for endovascular treatment of intracranial aneurysms and improves the success rate. However, it also increases the risk of ischemic complications in patients. The current standard dual antiplatelet regimen is considered crucial in reducing thrombotic events. Nevertheless, some patients exhibit resistance to antiplatelet drugs, which puts them at a higher risk of thrombotic events. In clinical practice, there is a lack of standardized platelet function testing and consensus on adjusting antiplatelet drug programs. This study conducted a multi-center, prospective cluster randomized controlled trial to investigate whether antiplatelet adjustment therapy guided by light transmittance aggregometry (LTA) detection can decrease the occurrence of ischemic events after stent implantation in patients with unruptured intracranial aneurysms. Additionally, the study aimed to establish a set of standardized antiplatelet regimens.

Enrollment: 590 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with unruptured intracranial aneurysms who received intracranial stenting,
2. Standard dualantiplatelet therapy for at least 5 days before stent implantation,
3. Patients aged 18-80,
4. on the day of registration patients with a Modified Rankin Scale lower than 2,
5. patients who agree and sign the consent form.

Exclusion criteria

1. Patients with recurrent aneurysms after interventional therapy or clipping therapy,
2. Patients with a history of allergy to aspirin, clopidogrel or ticagrelor,
3. Patients who used tirofiban prophylactically before surgery,
4. Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction,
5. Any abnormal platelet count (normal value is 100-300 × 10^9/L),
6. Patients using anticoagulants,
7. Pregnant or lactating women,
8. Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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590 participants in 2 patient groups

control group

No Intervention group

Description:

Continue to use the center's original antiplatelet regimen: oral aspirin 100 mg and clopidogrel 75 mg daily

test group

Experimental group

Description:

Use a guided antiplatelet regimen based on LTA testing

Treatment:

Drug: Adjustment of Antiplatelet Drugs