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

NCT ID: NCT05841147

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2023-08-31

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.

Conditions

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Intracranial Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Tirofiban

Intervention Type DRUG

Intravenous administration of tirofiban

The control group

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

Group Type ACTIVE_COMPARATOR

normal saline

Intervention Type DRUG

Intravenous administration of normal saline

Interventions

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Tirofiban

Intravenous administration of tirofiban

Intervention Type DRUG

normal saline

Intravenous administration of normal saline

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lu Hua

OTHER

Sponsor Role lead

Responsible Party

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Lu Hua

Chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jiangsu Province Hospital

Nanjing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Lu Lu Hua

Role: CONTACT

18761671021

Lei Mao Mao Lei

Role: CONTACT

13057658078

Facility Contacts

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Lei Mao Mao Lei

Role: primary

13057658078

Hua Lu Lu Hua

Role: backup

18761671021

Other Identifiers

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ANHSI

Identifier Type: -

Identifier Source: org_study_id

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