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

Lu Hua

Status and phase: Enrolling; Phase 4

Conditions: Intracranial Aneurysm

Treatments: Drug: Tirofiban; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05841147

ANHSI

Details and patient eligibility

About

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?

Full description

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

The intervention group

Experimental group

Description:

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.

Treatment:

Drug: Tirofiban

The control group

Active Comparator group

Description:

The same dose of normal saline was used instead of tirofiban.

Treatment:

Drug: normal saline