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To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.
The standard treatment for acute ischemic stroke is intravenous thrombolysis to dissolve fibrin and restore blood flow. However, reocclusion of blood vessels and stroke progression remain challenges after this treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous thrombolysis plus tirofiban administration | Experimental | Patients will receive Intravenous thrombolysis and tirofiban administration |
|
| Intravenous thrombolysis plus placebo administration | Active Comparator | Patients will receive Intravenous thrombolysis and placebo (saline) administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous thrombolysis plus tirofiban | Drug | Patients randomized to the Tirofiban group will receive continuous intravenous infusion of tirofiban for 24 hours: initial infusion of 0.4 μg/kg/min for 30 minutes followed by a continuous infusion of 0.1 μg/kg/min for up to 23.5 hours. The tirofiban placebo will be infused in a similar fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| a modified Rankin Score of 0-1 | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90 (± 14 days) after procedure |
| mortality | (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100% | 90 (± 14 days) after procedure |
| symptomatic intracerebral hemorrhage (ICH) | SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 36 hours or any hemorrhage leading to death. | within 36 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| a modified Rankin Score of 0-3 | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90 (± 14 days) after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | 230001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39501470 | Result | Tao C, Liu T, Sun J, Zhu Y, Li R, Wang L, Zhang C, Song J, Jing X, Nguyen TN, Nogueira RG, Saver JL, Hu W. Advancing stroke safety and efficacy through early tirofiban administration after intravenous thrombolysis: The multicenter, randomized, placebo-controlled, double-blind ASSET IT trial protocol. Int J Stroke. 2025 Mar;20(3):373-377. doi: 10.1177/17474930241299666. Epub 2024 Nov 20. | |
| 40616232 |
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randomized, double-blind trial
|
| Intravenous thrombolysis plus placebo | Drug | placebo (saline) |
|
| Modified Rankin Score |
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
| 90 (± 14 days) after procedure |
| NIHSS score | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | 24 hours after procedure |
| Derived |
| Tao C, Liu T, Cui T, Liu J, Li Z, Ren Y, Zhao X, Xie F, Li J, Wang H, Huang L, Li J, Wen J, Zeng J, Zhu J, Li Z, Li D, Hu X, Huang B, Wang J, Zhang C, Ye B, Hou Y, Gan Y, Sun H, Guan F, Shao Y, Liu Z, Ou Z, Fan S, Wang Y, Zhai H, Ni C, Wang H, Zhang C, Zhao Y, Wang G, Zhu Y, Li R, Sun J, Hu H, Cui J, Wang L, Zhang C, Song J, Jing X, Wang A, Wang J, Xu P, Qureshi AI, Nguyen TN, Nogueira RG, Saver JL, Hu W; ASSET-IT Investigators. Early Tirofiban Infusion after Intravenous Thrombolysis for Stroke. N Engl J Med. 2025 Sep 25;393(12):1191-1201. doi: 10.1056/NEJMoa2503678. Epub 2025 Jul 4. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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