Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial Protocol
Background It is common that symptoms do not improve or even worsen after intravenous thrombolysis (IVT) in acute ischemic stroke. However, it remains unknown whether early administration of tirofiban after IVT may improve clinical outcomes. This trial aims to assess the efficacy and safety of early...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-07-01
|
| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.124.038536 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849245446720978944 |
|---|---|
| author | Fan Zhang Minghui Xiao Cong Zhang Guangxiong Yuan Zhiyong Xie Yi Yin Ruize Zhou Shanggui Yuan Genxiang Xiao Donghuan Mei Xiaobing Zeng Huashi Liu Huadong Li Hongwen Liu Jinchang Tan Bin Chen Qingqing Fu Bin Li Jinxing Lai Wei Sun Shuhua Xie Zhaohui Lai Zhongming Qiu Zidian Jiang Xianghong Liu Guoyong Zeng |
| author_facet | Fan Zhang Minghui Xiao Cong Zhang Guangxiong Yuan Zhiyong Xie Yi Yin Ruize Zhou Shanggui Yuan Genxiang Xiao Donghuan Mei Xiaobing Zeng Huashi Liu Huadong Li Hongwen Liu Jinchang Tan Bin Chen Qingqing Fu Bin Li Jinxing Lai Wei Sun Shuhua Xie Zhaohui Lai Zhongming Qiu Zidian Jiang Xianghong Liu Guoyong Zeng |
| author_sort | Fan Zhang |
| collection | DOAJ |
| description | Background It is common that symptoms do not improve or even worsen after intravenous thrombolysis (IVT) in acute ischemic stroke. However, it remains unknown whether early administration of tirofiban after IVT may improve clinical outcomes. This trial aims to assess the efficacy and safety of early administration of tirofiban after IVT with tenecteplase in acute ischemic stroke during the 90‐day follow‐up period after treatment. Methods The INSTANT (Intravenous Tenecteplase and Tirofiban for Acute Ischemic Stroke) trial is an investigator‐initiated, randomized, placebo‐controlled, double‐blind, multicenter trial. In the study, 310 patients with acute nonlarge/medium‐sized vascular occlusion and nonatrial fibrillation stroke who are treated with intravenous tenecteplase will be consecutively randomized to intravenous tirofiban or placebo in a 1:1 ratio over 2 years across 50 intravenous thrombolysis‐capable stroke centers in China. In addition, eligible subjects will receive best medical treatment according to national guidelines. The primary efficacy end point is excellent functional status, defined as a score of 0 or 1 on the modified Rankin Scale at 90 days after randomization. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours and mortality at 90 days. Conclusions The INSTANT trial was designed to determine the role of tirofiban within 24 hours after IVT in patients with acute ischemic stroke. Our primary objective is to investigate whether the early administration of tirofiban following IVT can enhance the proportion of patients exhibiting no or minimal symptoms post acute ischemic stroke. Registration URL: ChiCTR2300074368; Unique Identifier: www.chictr.org.cn. |
| format | Article |
| id | doaj-art-4736f1fe09644f409cb954f78b6c71e4 |
| institution | Kabale University |
| issn | 2047-9980 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-4736f1fe09644f409cb954f78b6c71e42025-08-20T03:58:49ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802025-07-01141310.1161/JAHA.124.038536Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial ProtocolFan Zhang0Minghui Xiao1Cong Zhang2Guangxiong Yuan3Zhiyong Xie4Yi Yin5Ruize Zhou6Shanggui Yuan7Genxiang Xiao8Donghuan Mei9Xiaobing Zeng10Huashi Liu11Huadong Li12Hongwen Liu13Jinchang Tan14Bin Chen15Qingqing Fu16Bin Li17Jinxing Lai18Wei Sun19Shuhua Xie20Zhaohui Lai21Zhongming Qiu22Zidian Jiang23Xianghong Liu24Guoyong Zeng25Ganzhou People’s Hospital Ganzhou ChinaPeople’s Hospital of Wan’an City Wan’an ChinaGanzhou People’s Hospital Ganzhou ChinaXiangtan Central Hospital Xiangtan ChinaPeople’s Hospital of Yudu City Yudu ChinaPeople’s Hospital of Shangyou City Shangyou ChinaPeople’s Hospital of RuiJin City RuiJin ChinaSecond Hospital of Xingguo City Xingguo ChinaPeople’s Hospital of ShiCheng City ShiCheng ChinaPeople’s Hospital of County Xunwu Xunwu ChinaPeople’s Hospital of Anyuan City Anyuan ChinaPeople’s Hospital of Dayu City Dayu ChinaPeople’s Hospital of Chongyi City Chongyi ChinaGanzhou Municipal Hospital Ganzhou ChinaTraditional Chinese Medicine Hospital of Yudu City Yudu ChinaPeople’s Hospital of Quannan City Quannan ChinaGanzhou People’s Hospital Ganzhou ChinaGanzhou People’s Hospital Ganzhou ChinaGanzhou People’s Hospital Ganzhou ChinaGanzhou People’s Hospital Ganzhou ChinaGanzhou People’s Hospital Ganzhou ChinaGanzhou People’s Hospital Ganzhou ChinaThe 903rd Hospital of the People’s Liberation Army Hangzhou ChinaZhongmeng Hospital of Hexigten Banner Chifeng City Hexigten Banner ChinaGanzhou People’s Hospital Ganzhou ChinaGanzhou People’s Hospital Ganzhou ChinaBackground It is common that symptoms do not improve or even worsen after intravenous thrombolysis (IVT) in acute ischemic stroke. However, it remains unknown whether early administration of tirofiban after IVT may improve clinical outcomes. This trial aims to assess the efficacy and safety of early administration of tirofiban after IVT with tenecteplase in acute ischemic stroke during the 90‐day follow‐up period after treatment. Methods The INSTANT (Intravenous Tenecteplase and Tirofiban for Acute Ischemic Stroke) trial is an investigator‐initiated, randomized, placebo‐controlled, double‐blind, multicenter trial. In the study, 310 patients with acute nonlarge/medium‐sized vascular occlusion and nonatrial fibrillation stroke who are treated with intravenous tenecteplase will be consecutively randomized to intravenous tirofiban or placebo in a 1:1 ratio over 2 years across 50 intravenous thrombolysis‐capable stroke centers in China. In addition, eligible subjects will receive best medical treatment according to national guidelines. The primary efficacy end point is excellent functional status, defined as a score of 0 or 1 on the modified Rankin Scale at 90 days after randomization. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours and mortality at 90 days. Conclusions The INSTANT trial was designed to determine the role of tirofiban within 24 hours after IVT in patients with acute ischemic stroke. Our primary objective is to investigate whether the early administration of tirofiban following IVT can enhance the proportion of patients exhibiting no or minimal symptoms post acute ischemic stroke. Registration URL: ChiCTR2300074368; Unique Identifier: www.chictr.org.cn.https://www.ahajournals.org/doi/10.1161/JAHA.124.038536acute ischemic strokeexcellent outcomeintravenous thrombolysisprotocolrandomized trialtenecteplase |
| spellingShingle | Fan Zhang Minghui Xiao Cong Zhang Guangxiong Yuan Zhiyong Xie Yi Yin Ruize Zhou Shanggui Yuan Genxiang Xiao Donghuan Mei Xiaobing Zeng Huashi Liu Huadong Li Hongwen Liu Jinchang Tan Bin Chen Qingqing Fu Bin Li Jinxing Lai Wei Sun Shuhua Xie Zhaohui Lai Zhongming Qiu Zidian Jiang Xianghong Liu Guoyong Zeng Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial Protocol Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease acute ischemic stroke excellent outcome intravenous thrombolysis protocol randomized trial tenecteplase |
| title | Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial Protocol |
| title_full | Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial Protocol |
| title_fullStr | Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial Protocol |
| title_full_unstemmed | Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial Protocol |
| title_short | Effect of Intravenous Tirofiban Versus Placebo on Excellent Outcome in Patients With Acute Ischemic Stroke: The Multicenter, Randomized INSTANT Trial Protocol |
| title_sort | effect of intravenous tirofiban versus placebo on excellent outcome in patients with acute ischemic stroke the multicenter randomized instant trial protocol |
| topic | acute ischemic stroke excellent outcome intravenous thrombolysis protocol randomized trial tenecteplase |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.124.038536 |
| work_keys_str_mv | AT fanzhang effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT minghuixiao effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT congzhang effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT guangxiongyuan effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT zhiyongxie effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT yiyin effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT ruizezhou effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT shangguiyuan effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT genxiangxiao effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT donghuanmei effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT xiaobingzeng effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT huashiliu effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT huadongli effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT hongwenliu effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT jinchangtan effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT binchen effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT qingqingfu effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT binli effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT jinxinglai effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT weisun effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT shuhuaxie effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT zhaohuilai effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT zhongmingqiu effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT zidianjiang effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT xianghongliu effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol AT guoyongzeng effectofintravenoustirofibanversusplaceboonexcellentoutcomeinpatientswithacuteischemicstrokethemulticenterrandomizedinstanttrialprotocol |