Unruptured Intracranial AneurysmPhase 2/3TEARNCT06238115
Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair
A Phase 2/3 study testing Tirofiban and aspirin, clopidogrel in people with Unruptured Intracranial Aneurysm and Flow Diverter, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Flow Diverter, Stent-assisted Coiling
- What is being tested?
- Tirofiban and aspirin, clopidogrel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 9 Nov 2025
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-80.
- Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.
- Completion of preoperative antiplatelet preparation.
- Signed informed consent.
Who cannot join
- Abnormal platelet count (normal reference is 100-300×10^9/L).
- Allergy to study drugs and anesthetics.
- Contradictory to MRI examination.
- Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).
- Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.
- Clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
Show all 12Show fewer
- Antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days;
- Participants with recurrent aneurysms who have received neurointerventional treatment.
- Inability to follow endovascular procedures due to anatomical difficulties.
- Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency.
- Severe heart failure (NYHA classes III and IV) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope.
- Pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms
To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.
Read the detailed description
Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.
- Conditions
- Unruptured Intracranial Aneurysm, Flow Diverter, Stent-assisted Coiling, Thromboembolic Events
- Being tested
- Tirofiban, aspirin, clopidogrel
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours.
aspirin, clopidogrelDrug
aspirin 100 mg/day, clopidogrel 75 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban group | Experimental | After femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Receives: Drug: Tirofiban; Drug: aspirin, clopidogrel |
| Standard medical care | Placebo comparator | Routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) Receives: Drug: aspirin, clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
Measured: within 48 hours after procedure
The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
Measured: within 48 hours after procedure
Secondary outcomes (5)
Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.
Measured: at postoperative 48-hour and 30-day
Incidence of ischemic stroke within 48-hour and 30-day after procedure.
Measured: at postoperative 48-hour and 30-day
Incidence of transient ischemic attack within 48-hour and 30-day after procedure.
Measured: at postoperative 48-hour and 30-day
Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.
Measured: at postoperative 48-hour and 30-day
Disabling stroke within 30-day after procedure.
Disabling stroke is defined as modified Rankin Scale score >1. The modified Rankin Scale score ranges from 0 to 6, and the higher the score, the greater the degree of disability.
Measured: at postoperative 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start4 Mar 2024
- Primary completion9 Oct 2025
- Study completion9 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Jing, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238115
- Sponsor's protocol ID
- CSA2022KY009
- Acronym
- TEAR
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu X, Jiang Q, Wang N, Liu Q, Li S, Wang P, Ling C, Wang A, Zhang Z, Cao J, Yang X, Wang Y, Xie X, Jing J, Liu L. Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair (TEAR): A Phase 2, Randomized, Open-Label, Blinded End Point, Controlled Trial. Stroke. 2026 Aug;57(8):2295-2304. doi: 10.1161/STROKEAHA.126.056558. Epub 2026 Jun 12.
PubMed 42283072
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Administration of Tirofiban for Preventing Thromboembolic Events in Stent-assisted Coiling and Flow Diversion Treatments of Unruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT06238115
- Acronym / sponsor ID
- TEAR / CSA2022KY009
- Conditions
- Unruptured Intracranial Aneurysm, Flow Diverter, Stent-assisted Coiling, Thromboembolic Events
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Nov 2025 (actual)
- First posted
- 2 Feb 2024 (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.
To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.
Detailed description
Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban group | Experimental | Drug: Tirofiban, Drug: aspirin, clopidogrelAfter femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. |
| Standard medical care | Placebo comparator | Drug: aspirin, clopidogrelRoutine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-80.
- Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.
- Completion of preoperative antiplatelet preparation.
- Signed informed consent.
Key exclusion criteria (12 listed)
- Abnormal platelet count (normal reference is 100-300×10^9/L).
- Allergy to study drugs and anesthetics.
- Contradictory to MRI examination.
- Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).
- Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.
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 |
|---|---|---|
| TirofibanInitial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. | Drug | Tirofiban group |
| aspirin, clopidogrelaspirin 100 mg/day, clopidogrel 75 mg/day | Drug | Standard medical care, Tirofiban group |
Primary outcome
The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
Time frame: within 48 hours after procedure
The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure.
Time frame: within 48 hours after procedure
5 secondary outcomes
Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Incidence of ischemic stroke within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Incidence of transient ischemic attack within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure.
Time frame: at postoperative 48-hour and 30-day
Disabling stroke within 30-day after procedure.
Time frame: at postoperative 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Derived from this study: PubMed 42283072Hu X, Jiang Q, Wang N, Liu Q, Li S, Wang P, Ling C, Wang A, Zhang Z, Cao J, Yang X, Wang Y, Xie X, Jing J, Liu L. Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair (TEAR): A Phase 2, Randomized, Open-Label, Blinded End Point, Controlled Trial. Stroke. 2026 Aug;57(8):2295-2304. doi: 10.1161/STROKEAHA.126.056558. Epub 2026 Jun 12.
- Individual participant dataSharing planned: No
Related trials for Unruptured Intracranial Aneurysm
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
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.
Jing Jing study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tirofiban and aspirin, clopidogrel in people with Unruptured Intracranial Aneurysm and Flow Diverter, run by Beijing Tiantan Hospital 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 12 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: finished, as of the sponsor's last update on 11 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure. (time frame: within 48 hours after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06238115, which also lists 1 linked publication.
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 11 Dec 2025.