Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ganzhou City People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.
Intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. Previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. After thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirofiban | Experimental | Patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the tirofiban group will be treated with intravenous tirofiban. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Tirofiban will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days. |
|
| Placebo | Placebo Comparator | All patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the placebo group will be treated with intravenous saline. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Placebo will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban Hydrochloride | Drug | Patients will receive a continuous intravenous infusion of tirofiban at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h after start of tenecteplase treatment within 4-24 hours. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent functional outcome | modified Rankin scale score of 0 to 1. modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death. | 90 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal degree of disability | Ordinal degree of disability on the modified Rankin scale score at 90 days (shift analysis) | 90 days post-randomization |
| Functionally independent | modified Rankin scale score of 0 to 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal degree of disability | Ordinal degree of disability on the modified Rankin scale score at 1 year (shift analysis) | 1 year post-randomization |
| Excellent functional status | modified Rankin scale score 0 to 1 at 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deyan Kong, MD | Contact | +8618376635080 | kongdeyangxnn@163.com | |
| Guoyong Zeng, MD | Contact | +8613507079530 | hsyygy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhongming Qiu, MD | Sun Yet-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mingguang People's Hospital | Recruiting | Chuzhou | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42100960 | Derived | INSTANT Trial Authors for the INSTANT Investigators; Liu X, Zhang F, Zhang C, Li Z, Yuan G, Kong D, Xie S, Zhou M, Ye J, Lai Z, Li D, Xu H, Chen L, Cheng F, Shi Y, Chen B, Hu W, Liu H, Yin Y, Deng X, Xie Z, Li C, Shi J, Mei D, Liu B, Wang B, Zhou R, Liu J, Shen L, Hu H, Xiao G, Guan X, Yuan S, Lv X, Liang S, Zeng X, Chen Y, Cao W, Zheng C, Liu Y, Li J, Guan B, Lai T, Sun W, Zeng H, Zhang J, Li S, Sang H, Tang Y, Wang D, Lu M, Kaesmacher J, Yogendrakumar V, Pan S, Nogueira RG, Hong D, Goyal M, Thomalla G, Nguyen TN, Saver JL, Yang Q, Qiu Z, Zeng G. Intravenous Tirofiban After Tenecteplase in Acute Ischemic Stroke: The INSTANT Randomized Clinical Trial. JAMA. 2026 Jun 9;335(22):1949-1958. doi: 10.1001/jama.2026.5245. |
Not provided
Not provided
Study Protocol, Statistical Analysis Plan, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.
3 years after the trial results are revealed.
After approval of a proposal from principal investigator
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Patients will receive a continuous intravenous infusion of placebo at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h after start of tenecteplase treatment within 4-24 hours. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days. |
|
| 90 days post-randomization |
| Ambulatory or bodily needs capable or better | modified Rankin scale score of 0 to 3 | 90 days post-randomization |
| Early neurologic improvement | defined as the National Institutes of Health Stroke Scale score at 48 hours after randomization, is reduced by 30% or more compared to the National Institutes of Health Stroke Scale score at randomization | 48 hours post-randomization |
| Health-related quality of life | assessed with the European Quality Five Dimensions Five Level scale | 90 days post-randomization |
| Symptomatic intracranial hemorrhage | defined as per the Heidelberg bleeding classification | 48 hours post-randomization |
| Radiologic intracranial hemorrhage rate | diagnosed with intracranial hemorrhage (including bleeding in brain parenchyma, subarachnoid space, etc.) via radiologic examinations (e.g., computed tomography or magnetic resonance imaging | 48 hours post-randomization |
| Mortality | The proportion of participants who die from any cause within 90 days after randomization in the study | 90 days post-randomization |
| Incidence of non-hemorrhagic serious adverse events | such as pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc | Within 90 days post-randomization |
| Other serious adverse events | Serious adverse events that are not categorized as non-hemorrhagic (as listed in Outcome 10), including any unlisted severe medical events requiring medical intervention or leading to significant clinical deterioration | Within 90 days post-randomization |
| 1 year post-randomization |
| Functionally independent | modified Rankin scale score 0 to 2 at 1 year | 1 year post-randomization |
| Ambulatory or bodily needs capable or better | modified Rankin scale score 0 to 3 at 1 year | 1 year post-randomization |
| Longyan People´s Hospital, Longyan City | Recruiting | Longyan | Fujian | China |
|
| The Second Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
|
| Huangmei People's Hospital | Recruiting | Huanggang | Hubei | China |
|
| Yiling People's Hospital of Yichang city | Recruiting | Yichang | Hubei | China |
|
| Hunan Xupu Chengnan Hospital | Recruiting | Huaihua | Hunan | China |
|
| People's Hospital Of Shaodong | Recruiting | Shaoyang | Hunan | China |
|
| Shaoshan People's Hospital | Recruiting | Xiangtan | Hunan | China |
|
| Xiangtan Central Hospitall | Recruiting | Xiangtan | Hunan | China |
|
| Hunan University of Medicine Affiliated Pingjiang Hospital | Recruiting | Yueyang | Hunan | China |
|
| Ganzhou People's Hospital | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of Dayu County | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of Ganxian District | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of Quannan County | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of RuiJin City | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of Shangyou County | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of Xinfeng County | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of Xunwu County | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| People's Hospital of Yudu County | Recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| Ganzhou Municipal Hospital | Recruiting | Ganzhou | Jiangxi | China |
|
| Nankang TCM Hospital | Recruiting | Ganzhou | Jiangxi | China |
|
| People's Hospital of Anyuan County | Recruiting | Ganzhou | Jiangxi | China |
|
| People's Hospital of Chongyi County | Recruiting | Ganzhou | Jiangxi | China |
|
| People's Hospital of Shicheng County | Recruiting | Ganzhou | Jiangxi | China |
|
| Second Hospital of Xingguo County | Recruiting | Ganzhou | Jiangxi | China |
|
| Second People's Hospital of Yudu County | Recruiting | Ganzhou | Jiangxi | China |
|
| The People's Hospital of Ningdu County | Recruiting | Ganzhou | Jiangxi | China |
|
| Traditional Chinese Medicine Hospital of Xingguo County | Recruiting | Ganzhou | Jiangxi | China |
|
| Traditional Chinese Medicine Hospital of Yudu County | Recruiting | Ganzhou | Jiangxi | China |
|
| Affiliated Hospital of Jiujiang University | Recruiting | Jiujiang | Jiangxi | China |
|
| Ji'an Central People's Hospital | Recruiting | Ji’an | Jiangxi | China |
|
| People's Hospital of Wan'an county | Recruiting | Ji’an | Jiangxi | China |
|
| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | Jiangxi | China |
|
| People's Hospital of Yichun | Recruiting | Yichun | Jiangxi | China |
|
| Yingtan People's Hospital | Recruiting | Yingtan | Jiangxi | China |
|
| Songyuan Jilin Oilfield Hospital | Recruiting | Songyuan | Jilin | China |
|
| Dalian Municipal Central Hospital | Recruiting | Dalian | Liaoning | China |
|
| Zhongmeng Hospital of Hexigten Banner | Recruiting | Chifeng | Neimenggu | China |
|
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided