Acute Ischemic StrokePhase 3INSTANTNCT05604638
Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
A Phase 3 study testing Tirofiban Hydrochloride in people with Acute Ischemic Stroke, run by Second Affiliated Hospital of Guangxi Medical University at 38 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tirofiban Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 38 sitesChina
- Study dates
- 24 Apr 2024to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more);
- NIHSS ≥ 4 points before randomization;
- The patient or their family members sign a written informed consent form.
Who cannot join
- Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
- CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery;
- Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction <40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score ≥ 2 indicating high thromboembolic risk;
- Blood platelet count was lower than 100×10^9/L;
- Renal insufficiency, glomerular filtration rate < 30 mL/min;
- Pregnant or lactating women;
Show all 13Show fewer
- Allergic to tirofiban, nickel, titanium or their alloys;
- Prior neurological or psychiatric illness that prevents assessment of neurological function;
- Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
- Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
- Intracranial aneurysm, arteriovenous malformation;
- Life expectancy of any advanced disease < 6 months;
- Participating in other clinical trials.
Trial locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
38 sites in 1 country
China38 sites, 38 recruiting
- Recruiting
Zhongmeng Hospital of Hexigten Banner
Chifeng, Neimenggu
Dan Li
Guozhi Lu
- Recruiting
Mingguang People's Hospital
Chuzhou, Anhui
Zongliang Li,
Lei Chen
- Recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning
Zhongjun Chen
Manhong zhao
- Recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000
Guoyong Zeng, MD, +8613507079530, hsyygy@163.com
Fan Zhang, +8618970148470
- Recruiting
People's Hospital of Dayu County
Ganzhou, Jiangxi, 341000
Huashi Liu,
Yongfang Deng
- Recruiting
People's Hospital of Ganxian District
Ganzhou, Jiangxi, 341000
Weihua Hu,
Jianyong Chen
- Recruiting
People's Hospital of Quannan County
Ganzhou, Jiangxi, 341000
Bin Chen
Qiang Li
- Recruiting
People's Hospital of RuiJin City
Ganzhou, Jiangxi, 341000
Ruize Zhou
Xiaomei Lai
- Recruiting
People's Hospital of Shangyou County
Ganzhou, Jiangxi, 341000
Yi Yin
Daofei Liu
- Recruiting
People's Hospital of Xinfeng County
Ganzhou, Jiangxi, 341000
Yan Shi
Qing Chen
- Recruiting
People's Hospital of Xunwu County
Ganzhou, Jiangxi, 341000
Donghuan Mei
Hailin Yan
- Recruiting
People's Hospital of Yudu County
Ganzhou, Jiangxi, 341000
Zhiyong Xie,
Qingfeng Zeng
- Recruiting
Ganzhou Municipal Hospital
Ganzhou, Jiangxi
Hongwen Liu
Jiangqiang Lai
- Recruiting
Nankang TCM Hospital
Ganzhou, Jiangxi
Fangwei Li
Long Gao
- Recruiting
People's Hospital of Anyuan County
Ganzhou, Jiangxi
Hong Zhang
Xiaobin Zeng
- Recruiting
People's Hospital of Chongyi County
Ganzhou, Jiangxi
Xunwei Lv,
Huadong Li
- Recruiting
People's Hospital of Shicheng County
Ganzhou, Jiangxi
Gengxiang Xiao
Longshen Huang
- Recruiting
Second Hospital of Xingguo County
Ganzhou, Jiangxi
Shanggui Yuan
Yanmao Liu
- Recruiting
Second People's Hospital of Yudu County
Ganzhou, Jiangxi
Xiaoyu Guan,
Luyang Wang
- Recruiting
The People's Hospital of Ningdu County
Ganzhou, Jiangxi
Hairong Hu,
Jian Xiao
- Recruiting
Traditional Chinese Medicine Hospital of Xingguo County
Ganzhou, Jiangxi
Shuiping Liang
Xiankun Yang
- Recruiting
Traditional Chinese Medicine Hospital of Yudu County
Ganzhou, Jiangxi
Jinchang Tan
Guozhen Liu
- Recruiting
Hunan Xupu Chengnan Hospital
Huaihua, Hunan
Bo Wang
Bin Zhang
- Recruiting
Huangmei People's Hospital
Huanggang, Hubei
Junfeng Shi
Hongtao Huo
- Recruiting
Ji'an Central People's Hospital
Ji’an, Jiangxi
Yi Chen
- Recruiting
People's Hospital of Wan'an county
Ji’an, Jiangxi
Bin Liu
Wenbin Qiu
- Recruiting
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi
Zhongbin Xia
Ye Liu
- Recruiting
Longyan People´s Hospital, Longyan City
Longyan, Fujian
Yuqin Deng
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Wenfeng Cao
Zhengbing Xiang
- Recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Deyan Kong, MD
- Recruiting
People's Hospital Of Shaodong
Shaoyang, Hunan
Limin Shen
- Recruiting
Songyuan Jilin Oilfield Hospital
Songyuan, Jilin
Ying Jin
Chunying Li
- Recruiting
Shaoshan People's Hospital
Xiangtan, Hunan
Zhenhua Xiao
Shuai Zhao
- Recruiting
Xiangtan Central Hospitall
Xiangtan, Hunan
Guangxiong Yuan
Junxiong Wu
- Recruiting
Yiling People's Hospital of Yichang city
Yichang, Hubei
Hailong Xu
Zhenxing Liu
- Recruiting
People's Hospital of Yichun
Yichun, Jiangxi
Xinbo Deng
Ling Gao
- Recruiting
Yingtan People's Hospital
Yingtan, Jiangxi
Jingjing Liu
Tianpei Li
- Recruiting
Hunan University of Medicine Affiliated Pingjiang Hospital
Yueyang, Hunan
Xiang Zeng
Sire Li
About this study
Official title: Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban Hydrochloride, Placebo
- Keywords
- randomized trial, tenecteplase, tirofiban, intravenous thrombolysis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirofiban HydrochlorideDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tirofiban Hydrochloride |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days post-randomization
Secondary outcomes (10)
Ordinal degree of disability
Ordinal degree of disability on the modified Rankin scale score at 90 days (shift analysis)
Measured: 90 days post-randomization
Functionally independent
modified Rankin scale score of 0 to 2
Measured: 90 days post-randomization
Ambulatory or bodily needs capable or better
modified Rankin scale score of 0 to 3
Measured: 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
Measured: 48 hours post-randomization
Health-related quality of life
assessed with the European Quality Five Dimensions Five Level scale
Measured: 90 days post-randomization
Symptomatic intracranial hemorrhage
defined as per the Heidelberg bleeding classification
Measured: 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
Measured: 48 hours post-randomization
Mortality
The proportion of participants who die from any cause within 90 days after randomization in the study
Measured: 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
Measured: 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
Measured: Within 90 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start24 Apr 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ganzhou City People's Hospital
- Responsible party
- Principal investigator, Jian Zhang, MD, Second Affiliated Hospital of Guangxi Medical University
- Investigators
- Zhongming Qiu, MD, Principal investigator, Sun Yet-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604638
- Sponsor's protocol ID
- SecondAHGuangxiMU
- Acronym
- INSTANT
- Status last verified
- Dec 2025
- First submitted
- 28 Oct 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 42100960
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05604638
- Acronym / sponsor ID
- INSTANT / SecondAHGuangxiMU
- Conditions
- Acute Ischemic Stroke
- Keywords
- randomized trial, tenecteplase, tirofiban, intravenous thrombolysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Ganzhou City People's Hospital
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban | Experimental | Drug: Tirofiban HydrochloridePatients 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 | Drug: PlaceboAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old;
- Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more);
- NIHSS ≥ 4 points before randomization;
- The patient or their family members sign a written informed consent form.
Key exclusion criteria (13 listed)
- Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
- CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery;
- Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction <40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score ≥ 2 indicating high thromboembolic risk;
- Blood platelet count was lower than 100×10^9/L;
- Renal insufficiency, glomerular filtration rate < 30 mL/min;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tirofiban HydrochloridePatients 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. | Drug | Tirofiban |
| PlaceboPatients 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. | Drug | Placebo |
Primary outcome
Excellent functional outcome
Time frame: 90 days post-randomization
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.
10 secondary outcomes
Ordinal degree of disability
Time frame: 90 days post-randomization
Functionally independent
Time frame: 90 days post-randomization
Ambulatory or bodily needs capable or better
Time frame: 90 days post-randomization
Early neurologic improvement
Time frame: 48 hours post-randomization
Health-related quality of life
Time frame: 90 days post-randomization
Symptomatic intracranial hemorrhage
Time frame: 48 hours post-randomization
Radiologic intracranial hemorrhage rate
Time frame: 48 hours post-randomization
Mortality
Time frame: 90 days post-randomization
Incidence of non-hemorrhagic serious adverse events
Time frame: Within 90 days post-randomization
Other serious adverse events
Time frame: Within 90 days post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 42100960INSTANT 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhongming Qiu, MD principal investigator
Sun Yet-sen University
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirofiban Hydrochloride in people with Acute Ischemic Stroke, run by Second Affiliated Hospital of Guangxi Medical University at 38 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deyan Kong, MD (+8618376635080, kongdeyangxnn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent functional outcome (time frame: 90 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.