Intracranial AneurysmPhase 4NCT05841147
Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration of Tirofiban
A Phase 4 study testing Tirofiban and normal saline in people with Intracranial Aneurysm, run by Lu Hua at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Tirofiban and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- Hemorrhagic retinopathy;
- Chronic hemodialysis;
- Renal insufficiency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing
Lei Mao Mao Lei, 13057658078, 2165451550@qq.com
Hua Lu Lu Hua, 18761671021, luhua@njmu.edu.cn
About this study
Official title: Reduction of Microembolism After Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms by Administration of Tirofiban：A Randomized, Controlled, Double-blind Trial
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?
Read the detailed description
We aim to reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.
- Conditions
- Intracranial Aneurysm
- Being tested
- Tirofiban, normal saline
- Keywords
- Aneurysm, Tirofiban, Stent-Assisted Coil Embolization
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Intravenous administration of tirofiban
normal salineDrug
Intravenous administration of normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tirofiban |
| The control group | Active comparator | The same dose of normal saline was used instead of tirofiban. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microembolism
Number of microembolism
Measured: Within 72 hours after surgery
Secondary outcomes (1)
The incidence of microembolism
The incidence of microembolism
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start25 Apr 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Hua, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841147
- Sponsor's protocol ID
- ANHSI
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Microembolism After Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms by Administration of Tirofiban：A Randomized, Controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT05841147
- Acronym / sponsor ID
- ANHSI
- Conditions
- Intracranial Aneurysm
- Keywords
- Aneurysm, Tirofiban, Stent-Assisted Coil Embolization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lu HuaUniversity, hospital or other
- Study start
- 25 Apr 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Drug: TirofibanAn 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 | Active comparator | Drug: normal salineThe same dose of normal saline was used instead of tirofiban. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirofibanIntravenous administration of tirofiban | Drug | The intervention group |
| normal salineIntravenous administration of normal saline | Drug | The control group |
Primary outcome
Microembolism
Time frame: Within 72 hours after surgery
Number of microembolism
1 secondary outcome
The incidence of microembolism
Time frame: Within 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirofiban and normal saline in people with Intracranial Aneurysm, run by Lu Hua at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Lu Lu Hua (18761671021, luhua@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microembolism (time frame: Within 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.