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

Sponsor

Lu Hua (Other)

Overall Status

Recruiting

CT.gov ID

NCT05841147

Collaborator

(none)

Enrollment

Location

Arms

4.2

Anticipated Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	Drug: Tirofiban Drug: normal saline	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Blinding all personnel who may interfere with the trial results, such as Participant, Care Provider, Investigator and Outcomes Assessor

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 25, 2023

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Tirofiban Intravenous administration of tirofiban
Active Comparator: The control group The same dose of normal saline was used instead of tirofiban.	Drug: normal saline Intravenous administration of normal saline

Arm

Intervention/Treatment

Experimental: 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.

Drug: Tirofiban

Intravenous administration of tirofiban

Active Comparator: The control group

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

Drug: normal saline

Intravenous administration of normal saline

Outcome Measures

Primary Outcome Measures

Microembolism [Within 72 hours after surgery]
Number of microembolism

Secondary Outcome Measures

The incidence of microembolism [Within 48 hours after surgery]
The incidence of microembolism

Other Outcome Measures

Hemorrhage [Within 48 hours after surgery]
The incidence of Hemorrhage

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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;

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.