Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

Study Overview
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Brief Summary
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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.

Official Title
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Guided Versus Standard Antiplatelet Therapy in Intracranial Aneurysm Intervention With Stents: a Cluster Randomized Controlled Cohort Study

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Drug: Adjustment of Antiplatelet Drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unruptured intracranial aneurysms who received intracranial stenting, Standard dualantiplatelet therapy for at least 5 days before stent implantation, Patients aged 18-80, on the day of registration patients with a Modified Rankin Scale lower than 2, patients who agree and sign the consent form. Exclusion Criteria: Patients with recurrent aneurysms after interventional therapy or clipping therapy, Patients with a history of allergy to aspirin, clopidogrel or ticagrelor, Patients who used tirofiban prophylactically before surgery, 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, Any abnormal platelet count (normal value is 100-300 × 10^9/L), Patients using anticoagulants, Pregnant or lactating women, Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster randomized controlled cohort study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Continue to use the center's original antiplatelet regimen: oral aspirin 100 mg and clopidogrel 75 mg daily | |
| Experimental: test group<br>Use a guided antiplatelet regimen based on LTA testing | Drug: Adjustment of Antiplatelet Drugs<br>* The maximum platelet aggregation rate induced by arachidonic acid (AA-MPA)≥20%, give aspirin 200mg qd. The maximum platelet aggregation rate induced by adenosine diphosphatase (ADP-MPA)≥36.4% for flow diversion, give ticagrelor 60mg bid. ADP-MPA≥42.9% for stent-assisted coil embolization，give ticagrelor 60mg bid. ADP-MPA<20%, give clopidogrel 37.5mg qd. The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA testing should be performed again 48 hours after the drug adjustment. For patients whose ADP-MPA does not reach the normal range, a second antiplatelet drug adjustment should be performed: ticagrelor overdose: reduce to 45mg bid; ticagrelor resistance, increase to 90 mg bid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic events | ischemic stroke, transient ischemic stroke (TIA), stent thrombosis | 30 days after stent implantation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Aneurysm, Interventional Therapy, Stent, Platelet, Ischemic Stroke, Bleeding Event