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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05841147

Enrollment

Registered

2023-05-03

Start date

2023-04-25

Completion date

2023-08-31

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm

Keywords

Aneurysm, Tirofiban, Stent-Assisted Coil Embolization

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?

Detailed description

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

Interventions

DRUGTirofiban

Intravenous administration of tirofiban

DRUGnormal saline

Intravenous administration of normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Microembolism	Within 72 hours after surgery	Number of microembolism

Secondary

Measure	Time frame	Description
The incidence of microembolism	Within 48 hours after surgery	The incidence of microembolism

Other

Measure	Time frame	Description
Hemorrhage	Within 48 hours after surgery	The incidence of Hemorrhage

Countries

China

Contacts

Primary ContactHua Lu Lu Hua

luhua@njmu.edu.cn18761671021

Backup ContactLei Mao Mao Lei

2165451550@qq.com13057658078

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026