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

NCT05841147 | Unknown Phase 4 DMC

• 1 other identifier: ANHSI
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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?

Conditions

Intracranial Aneurysm

Keywords

Aneurysm; Tirofiban; Stent-Assisted Coil Embolization

Outcome Measures

Primary Outcomes (1)

• Microembolism

  Number of microembolism

  Within 72 hours after surgery

Secondary Outcomes (1)

• The incidence of microembolism

  Within 48 hours after surgery

Other Outcomes (1)

• Hemorrhage

  Within 48 hours after surgery

Study Arms (2)

The intervention group

EXPERIMENTAL

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

The control group

ACTIVE COMPARATOR

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

Drug: normal saline

Interventions

Tirofiban DRUG

Intravenous administration of tirofiban

The intervention group

normal saline DRUG

Intravenous administration of normal saline

The control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lu Hua: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Interventions

Tirofiban; Saline Solution

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Hua Lu Lu Hua

CONTACT

18761671021; luhua@njmu.edu.cn

Lei Mao Mao Lei

CONTACT

13057658078; 2165451550@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding all personnel who may interfere with the trial results, such as Participant, Care Provider, Investigator and Outcomes Assessor
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: April 25, 2023
• Primary Completion: July 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

CN (1)