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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard medical care | Placebo Comparator | Routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The volumes of ischemic lesions on diffusion weighted imaging within 48 hours after procedure. | within 48 hours after procedure | |
| The numbers of ischemic lesions on diffusion weighted imaging within 48 hours after procedure. | within 48 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Any new stroke events (ischemic stroke or hemorrhagic stroke) within 48-hour and 30-day after procedure. | at postoperative 48-hour and 30-day | |
| Incidence of ischemic stroke within 48-hour and 30-day after procedure. | at postoperative 48-hour and 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate and severe bleeding events according to the GUSTO criteria within 48-hour after procedure. | at postoperative 48-hour | |
| Moderate and severe bleeding events according to the GUSTO criteria within 30-day after procedure. | at postoperative 30-day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Jing | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42283072 | Derived | 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 TEAR: A Phase 2, Randomized, Open-Label, Blinded End Point, Controlled Trial. Stroke. 2026 Jun 12. doi: 10.1161/STROKEAHA.126.056558. Online ahead of print. |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| aspirin, clopidogrel | Drug | aspirin 100 mg/day, clopidogrel 75 mg/day |
|
| Incidence of transient ischemic attack within 48-hour and 30-day after procedure. | at postoperative 48-hour and 30-day |
| Incidence of ischemic stroke and transient ischemic attack within 48-hour and 30-day after procedure. | 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. | at postoperative 30-day |
| All bleeding events (severe/moderate bleeding and intracranial hemorrhage) within 48-hour and 30-day after procedure. | at postoperative 48-hour and 30-day |
| Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 48-hour and 30-day after procedure. | at postoperative 48-hour and 30-day |
| Total mortality within 48-hour and 30-day after procedure. | at postoperative 48-hour and 30-day |
| Adverse events/Severe adverse events reported by investigators within 48-hour and 30-day after procedure. | at postoperative 48-hour and 30-day |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |