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| Name | Class |
|---|---|
| Fujian Medical University Union Hospital | OTHER |
| Jingzhou Hospital Affiliated to Yangtze University | UNKNOWN |
| Xiangyang No 1 People's Hospital Affiliated to Hubei University of Medicine | UNKNOWN |
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Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset.
Endovascular treatment is the primary approach for significantly improving the clinical prognosis of patients with acute large vessel occlusion, and it has been consistently recommended by both domestic and foreign guidelines. Successful vascular recanalization and restoration of ischemic tissue reperfusion are crucial for the favorable prognosis of patients with large vessel occlusion. However, the rate of successful reperfusion after endovascular treatment exceeds 80%, but the rate of favorable outcomes at 90 days follow-up is less than 50%. The reasons for ineffective recanalization include reperfusion injury, arterial reocclusion, hemorrhagic transformation, and microvascular reperfusion insufficiency. Although vascular recanalization can be visualized using DSA, not all microvascular beds can be effectively perfused, and persistent microocclusion of the capillary bed in ischemic tissue will also result in a poor prognosis. Currently, drug intervention is not commonly utilized to achieve successful recanalization after mechanical thrombectomy in clinical practice. Additionally, there is a lack of effective methods to improve ineffective recanalization.
Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support.
This is a prospective, randomized, multicenter, double-blind clinical trial. In 52 centers in China, 1360 patients with the following situations will be enrolled: achieved successful recanalization after mechanical thrombectomy (mTICI 2b/3) within 24h of stroke onset.
Patients will be randomly assigned into 2 groups according to the ratio of 1:1:
The main measure of effectiveness was the rate of mRS 0-2 after 90 days, and the primary focus on safety was the rate of symptomatic intracranial hemorrhage within 48 hours. This study aims to clarify the role of tirofiban in enhancing unsuccessful recanalization after thrombectomy, which holds significant clinical value in improving the prognosis of patients following thrombectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirofiban group | Experimental | After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Tirofiban 5μg/kg was administered intravenously through the catheter artery at a rate of 1ml/min, followed by an intravenous infusion of 0.1μg/(kg·min) for 24 hours. Standard medical treatment was administered after the surgery. |
|
| placebo group | Placebo Comparator | After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the control group. Saline placebo was administered in the same manner as tirofiban group. Standard medical treatment was administered after the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban | Drug | After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Tirofiban 5μg/kg was administered intravenously through the catheter artery at a rate of 1ml/min, followed by an intravenous infusion of 0.1μg/(kg·min) for 24 hours. Standard medical treatment was administered after the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients functionally independent (mRS score 0 to 2) at 90 days | independent outcome at 90 days | 90 days after randomization |
| Number of participants with symptomatic intracranial hemorrhage | According to Heidelberg Bleeding Classification | within 48 hours of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Modified ranking scale (mRS) | A 0-6 scale running from perfect health without symptoms to death | 90 days after randomization |
| Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiang Luo | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 450001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35143603 | Background | Renu A, Millan M, San Roman L, Blasco J, Marti-Fabregas J, Terceno M, Amaro S, Serena J, Urra X, Laredo C, Barranco R, Camps-Renom P, Zarco F, Oleaga L, Cardona P, Castano C, Macho J, Cuadrado-Godia E, Vivas E, Lopez-Rueda A, Guimaraens L, Ramos-Pachon A, Roquer J, Muchada M, Tomasello A, Davalos A, Torres F, Chamorro A; CHOICE Investigators. Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial. JAMA. 2022 Mar 1;327(9):826-835. doi: 10.1001/jama.2022.1645. | |
| 28472526 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| Puren Hospital Affiliated to Wuhan University of Science and Technology | OTHER |
| Zhongnan Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Wuhan Central Hospital | OTHER |
| Xianning Central Hospital | OTHER |
| Shanxi Provincial People's Hospital | OTHER_GOV |
| The Third People's Hospital of Hubei Province | OTHER |
| Jingmen Central Hospital | UNKNOWN |
| Hubei University of Medicine | OTHER |
| Wuhan No.1 Hospital | OTHER |
| Nanyang Central Hospital | OTHER |
| Yichang Central People's Hospital of China Three Gorges University | UNKNOWN |
| The Central Hospital of Huanggang | OTHER |
| Zoucheng City People's Hospital | UNKNOWN |
| Qujing Central Hospital of Yunnan Province | UNKNOWN |
| Taihe Hospital, Affiliated Hospital of Hubei Province of Medicine | UNKNOWN |
| Second Affiliated Hospital of Soochow University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Central Hospital of Xiaogan | OTHER |
| The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture | OTHER |
| Huangshi Central Hospital | OTHER |
| Zigong No.1 Peoples Hospital | OTHER |
| Xiangyang Hospital of Traditional Chinese Medicine | OTHER |
| The First People's Hospital of Jingzhou City | UNKNOWN |
| First People's Hospital of Xianyang | OTHER |
| Jiujiang No.1 People's Hospital | OTHER |
| Zhongxiang Hospital of Traditional Chinese Medicine | UNKNOWN |
| Jiangxi Provincial People's Hopital | OTHER |
| The Lichuan ethnic Hospital of Traditional Chinese Medicine | UNKNOWN |
| Xiangyang Central Hospital People's Hospital of Huangpi District | UNKNOWN |
| Quanzhou First Hospital | OTHER |
| Minda Hospital of Hubei Minzu University | UNKNOWN |
| The Cerebrovascular Hospital of Hubei Province | UNKNOWN |
| The First People's Hospital of Changde City | OTHER |
| Longyan First Affiliated Hospital of Fujian Medical University | UNKNOWN |
| Xiangzhou People's Hospital | UNKNOWN |
| Jingmen People's Hospital | UNKNOWN |
| The First People's Hospital of TianMen in Hubei Province | UNKNOWN |
| Hanyang Hospital Affiliated to Wuhan University of Science and Technology | OTHER |
| Tongcheng People's Hospital | UNKNOWN |
| Gaoyou People's Hospital | UNKNOWN |
| Zaoyang First People's Hospital | UNKNOWN |
| CR & WISCO General Hospital | UNKNOWN |
| Wuhan Hankou Hospital | UNKNOWN |
| Lu'an People's Hospital of Anhui Hospital | UNKNOWN |
| Yingtan People's Hospital | UNKNOWN |
| Shiyan Renmin Hospital | UNKNOWN |
| Dali Bai Autonomous Prefecture People's Hospital | UNKNOWN |
| Three Gorges Hospital of Chongqing University | OTHER |
| The Second People's Hospital of Jingzhou City | UNKNOWN |
| General Hospital of the Yangtze River Shipping | UNKNOWN |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
| Fujian Provincial Hospital | OTHER |
| Zhongxiang People's Hospital | UNKNOWN |
| LiuZhou People's Hospital | OTHER |
| The Fifth Hospital of Wuhan | OTHER |
| Xiaogan First People's Hospital | UNKNOWN |
| Loudi Central Hospital | OTHER |
| Ezhou Central Hospital | OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| Qingdao Central Hospital | OTHER |
| Taizhou First People's Hospital | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| Hubei Provincial Hospital of Integrated Chinese & Western Medicine | UNKNOWN |
| The First Affiliated Hospital of BaoTou Medical College | OTHER |
| Xianfeng People's Hospital | UNKNOWN |
| Wuhan Third Hospital | OTHER |
| The Fourth Hospital of Wuhan | UNKNOWN |
| Chengdu Fifth People's Hospital | OTHER |
| Xingyi People's Hospital | UNKNOWN |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | OTHER |
| Shenzhen Hospital of Southern Medical University | OTHER |
| The Third People's Hospital of Jingzhou City | UNKNOWN |
| The First People's Hospital of Jiangxia District | UNKNOWN |
| Xihua People's Hospital | UNKNOWN |
| Shanghai East Hospital | OTHER |
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|
|
| Saline placebo | Drug | After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Saline placebo was administered in the same manner as tirofiban group. Standard medical treatment was administered after the surgery. |
|
Excellent functional outcome |
| 90 days after randomization |
| Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) | Ambulatory or bodily needs-capable or better | 90 days after randomization |
| Number of participants with improvement of neurological function | Proportion of patients with an NIHSS score of 0-1 or a reduction of ≥4 points from baseline at 36 hours (24-48 hours) of randomization | 36 hours (24-48 hours) after randomization |
| Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) | Health-related quality of life | 90 days after randomization |
| All-cause mortality | The ratio of total deaths from all causes to the research subjects at 90 days of randomization | 90 days after randomization |
| Proportion of intracranial hemorrhage of any type | Proportion of intracranial hemorrhage of any type within 48 hours of randomization | within 48 hours of randomization |
| Background |
| Dornbos D 3rd, Katz JS, Youssef P, Powers CJ, Nimjee SM. Glycoprotein IIb/IIIa Inhibitors in Prevention and Rescue Treatment of Thromboembolic Complications During Endovascular Embolization of Intracranial Aneurysms. Neurosurgery. 2018 Mar 1;82(3):268-277. doi: 10.1093/neuros/nyx170. |
| 37778035 | Background | Guan Q, Yun W, Li X, Ni H, Lv W, Xie Z, Zhang L, Zhou J, Xu Y, Li J, Zhang Q. Association of tirofiban with improvement of functional outcomes of direct thrombectomy for acute anterior circulation occlusion: a retrospective, nonrandomized, multicenter, real-world study. Neurosurg Focus. 2023 Oct;55(4):E21. doi: 10.3171/2023.7.FOCUS23150. |
| 35943471 | Background | RESCUE BT Trial Investigators; Qiu Z, Li F, Sang H, Luo W, Liu S, Liu W, Guo Z, Li H, Sun D, Huang W, Zhang M, Zhang M, Dai W, Zhou P, Deng W, Zhou Z, Huang X, Lei B, Li J, Yuan Z, Song B, Miao J, Liu S, Jin Z, Zeng G, Zeng H, Yuan J, Wen C, Yu Y, Yuan G, Wu J, Long C, Luo J, Tian Z, Zheng C, Hu Z, Wang S, Wang T, Qi L, Li R, Wan Y, Ke Y, Wu Y, Zhu X, Kong W, Huang J, Peng D, Chang M, Ge H, Shi Z, Yan Z, Du J, Jin Y, Ju D, Huang C, Hong Y, Liu T, Zhao W, Wang J, Zheng B, Wang L, Liu S, Luo X, Luo S, Xu X, Hu J, Pu J, Chen S, Sun Y, Jiang S, Wei L, Fu X, Bai Y, Yang S, Hu W, Zhang G, Pan C, Zhang S, Wang Y, Cao W, Yang S, Zhang J, Guo F, Wen H, Zhang J, Song J, Yue C, Li L, Wu D, Tian Y, Yang J, Lu M, Saver JL, Nogueira RG, Zi W, Yang Q. Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial. JAMA. 2022 Aug 9;328(6):543-553. doi: 10.1001/jama.2022.12584. |
| 36358016 | Background | Zhong HL, Zhou TF, He YK, Li TX, Li ZS. Safety and efficacy of adjunct tirofiban treatment following mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusion (LVO) resulting in successful reperfusion. Interv Neuroradiol. 2024 Oct;30(5):657-662. doi: 10.1177/15910199221138883. Epub 2022 Nov 10. |
| 42341797 | Derived | Huang H, Xu S, Qin T, Wang M, Li G, Liu C, Deng G, Wang Y, Ao D, Xie Y, Zhang Y, Kong Q, Lan L, Yu Y, Huang S, Yu Z, Yi T, Chen W, Zhao W, Su J, Zhou P, Li F, Mei B, Jing P, Zhang J, Du J, Goyal M, Nguyen TN, Wang D, Saver JL, Tang Z, Wang W, Luo X; ATTRACTION Investigators. Efficacy and safety of tirofiban after successful endovascular reperfusion in acute ischaemic stroke (ATTRACTION) in China: a multicentre, double-blind, randomised controlled trial. Lancet. 2026 Jun 24:S0140-6736(26)00983-9. doi: 10.1016/S0140-6736(26)00983-9. Online ahead of print. |
| 41991238 | Derived | Luo X, Huang H, Xu SB, Li G, Zhang Y, Luo Y, Kong Q, Xie Y, Liu CC, Deng G, Wang YH, Ao DH, Lan L, Yu Y, Tang Z, Wang W. Adjunct tirofiban treatment after successful endovascular thrombectomy recanalisation in acute anterior circulation ischaemic stroke (ATTRACTION): protocol of a multicentre, prospective, double-blinded, randomised trial. Stroke Vasc Neurol. 2026 Apr 16:svn-2025-004638. doi: 10.1136/svn-2025-004638. Online ahead of print. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |