Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban

Study Overview
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Brief Summary
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The goal of this clinical trial is to investigate whether intravenous injection of tilofiban can reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.The main questions it aims to answer are: Is it safe to inject tirofiban intravenously during interventional treatment of intracranial aneurysms？ What dose of tirofiban is safe and effective?

Detailed Description
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We aim to reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.

Official Title
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Reduction of Microembolism After Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms by Administration of Tirofiban：A Randomized, Controlled, Double-blind Trial

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Drug: Tirofiban
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age was between 18 and 75 years old; Unruptured aneurysm with surgical indications; Stent assisted coil embolization treatment was received ; The patient was willing to receive intervention treatment. Exclusion Criteria: Complicated with hemorrhagic cerebrovascular diseases such as cerebral vascular malformations and moyamoya disease or their medical history; Recent (within 1 year) bleeding symptoms such as gastrointestinal bleeding, clinically significant urinary/reproductive tract bleeding, and skin blueness; Dissecting aneurysm, pseudoaneurysm, and bullous aneurysm; A known history of coagulation disorders, platelet abnormalities, or thrombocytopenia; 5. Platelet count less than 150 × 109/L； A history of major surgical procedures or severe physical trauma within one month; Severe uncontrolled hypertension (systolic blood pressure>160mmHg and/or diastolic blood pressure>100mmHg); Hemorrhagic retinopathy; Chronic hemodialysis; Renal insufficiency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: The intervention group: An intravenous bolus (6µg/kg) over a 3 min period and a maintenance dose of 0.1µg/kg/min for 18 hour were used in this group. The control group: The same dose of normal saline was used instead of tirofiban.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group<br>An intravenous bolus (6µg/kg) over a 3 min period and a maintenance dose of 0.1µg/kg/min for 18 hour were used in this group. | Drug: Tirofiban<br>* Intravenous administration of tirofiban<br>|
| Active Comparator: The control group<br>The same dose of normal saline was used instead of tirofiban. | Drug: normal saline<br>* Intravenous administration of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microembolism | Number of microembolism | Within 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of microembolism | The incidence of microembolism | Within 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aneurysm, Tirofiban, Stent-Assisted Coil Embolization