Back to resultsReduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban
Primary Purpose
Intracranial Aneurysm
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tirofiban
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Intracranial Aneurysm focused on measuring Aneurysm, Tirofiban, Stent-Assisted Coil Embolization
Eligibility Criteria
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.
Sites / Locations
- Jiangsu Province HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The intervention group
The control group
Arm Description
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 same dose of normal saline was used instead of tirofiban.
Outcomes
Primary Outcome Measures
Microembolism
Number of microembolism
Secondary Outcome Measures
The incidence of microembolism
The incidence of microembolism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05841147
Brief Title
Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban
Official Title
Reduction of Microembolism After Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms by Administration of Tirofiban：A Randomized, Controlled, Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lu Hua
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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?
Detailed Description
We aim to reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Aneurysm, Tirofiban, Stent-Assisted Coil Embolization
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinding all personnel who may interfere with the trial results, such as Participant, Care Provider, Investigator and Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
The same dose of normal saline was used instead of tirofiban.
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Intervention Description
Intravenous administration of tirofiban
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Intravenous administration of normal saline
Primary Outcome Measure Information:
Title
Microembolism
Description
Number of microembolism
Time Frame
Within 72 hours after surgery
Secondary Outcome Measure Information:
Title
The incidence of microembolism
Description
The incidence of microembolism
Time Frame
Within 48 hours after surgery
Other Pre-specified Outcome Measures:
Title
Hemorrhage
Description
The incidence of Hemorrhage
Time Frame
Within 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Lu Lu Hua
Phone
18761671021
Email
luhua@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Mao Mao Lei
Phone
13057658078
Email
2165451550@qq.com
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Mao Mao Lei
Phone
13057658078
Email
2165451550@qq.com
First Name & Middle Initial & Last Name & Degree
Hua Lu Lu Hua
Phone
18761671021
Email
luhua@njmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban
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