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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841147
• Other study ID #: ANHSI
• Status: Recruiting
• Phase: Phase 4
• Start date: April 25, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Hua Lu Lu Hua
• Phone: 18761671021
• Email: luhua[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Drug:
• Tirofiban
Intravenous administration of tirofiban
• normal saline
Intravenous administration of normal saline

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Lu Hua

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemorrhage	The incidence of Hemorrhage	Within 48 hours after surgery
Primary	Microembolism	Number of microembolism	Within 72 hours after surgery
Secondary	The incidence of microembolism	The incidence of microembolism	Within 48 hours after surgery