Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
NCT ID: NCT05604638
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
348 participants
INTERVENTIONAL
2024-04-24
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tirofiban
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.
Tirofiban Hydrochloride
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.
Placebo
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.
Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tirofiban Hydrochloride
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.
Placebo
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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);
3. NIHSS ≥ 4 points before randomization;
4. The patient or their family members sign a written informed consent form.
Exclusion Criteria
2. 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;
3. 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;
4. Blood platelet count was lower than 100×10\^9/L;
5. Renal insufficiency, glomerular filtration rate \< 30 mL/min;
6. Pregnant or lactating women;
7. Allergic to tirofiban, nickel, titanium or their alloys;
8. Prior neurological or psychiatric illness that prevents assessment of neurological function;
9. Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
10. Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
11. Intracranial aneurysm, arteriovenous malformation;
12. Life expectancy of any advanced disease \< 6 months;
13. Participating in other clinical trials.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ganzhou People's Hospital
UNKNOWN
Second Affiliated Hospital of Guangxi Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jian Zhang, MD
Research assistant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhongming Qiu, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yet-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mingguang People's Hospital
Chuzhou, Anhui, China
Longyan People´s Hospital, Longyan City
Longyan, Fujian, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Huangmei People's Hospital
Huanggang, Hubei, China
Yiling People's Hospital of Yichang city
Yichang, Hubei, China
Hunan Xupu Chengnan Hospital
Huaihua, Hunan, China
People's Hospital Of Shaodong
Shaoyang, Hunan, China
Shaoshan People's Hospital
Xiangtan, Hunan, China
Xiangtan Central Hospitall
Xiangtan, Hunan, China
Hunan University of Medicine Affiliated Pingjiang Hospital
Yueyang, Hunan, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
People's Hospital of Dayu County
Ganzhou, Jiangxi, China
People's Hospital of Ganxian District
Ganzhou, Jiangxi, China
People's Hospital of Quannan County
Ganzhou, Jiangxi, China
People's Hospital of RuiJin City
Ganzhou, Jiangxi, China
People's Hospital of Shangyou County
Ganzhou, Jiangxi, China
People's Hospital of Xinfeng County
Ganzhou, Jiangxi, China
People's Hospital of Xunwu County
Ganzhou, Jiangxi, China
People's Hospital of Yudu County
Ganzhou, Jiangxi, China
Ganzhou Municipal Hospital
Ganzhou, Jiangxi, China
Nankang TCM Hospital
Ganzhou, Jiangxi, China
People's Hospital of Anyuan County
Ganzhou, Jiangxi, China
People's Hospital of Chongyi County
Ganzhou, Jiangxi, China
People's Hospital of Shicheng County
Ganzhou, Jiangxi, China
Second Hospital of Xingguo County
Ganzhou, Jiangxi, China
Second People's Hospital of Yudu County
Ganzhou, Jiangxi, China
The People's Hospital of Ningdu County
Ganzhou, Jiangxi, China
Traditional Chinese Medicine Hospital of Xingguo County
Ganzhou, Jiangxi, China
Traditional Chinese Medicine Hospital of Yudu County
Ganzhou, Jiangxi, China
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, China
Ji'an Central People's Hospital
Ji’an, Jiangxi, China
People's Hospital of Wan'an county
Ji’an, Jiangxi, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
People's Hospital of Yichun
Yichun, Jiangxi, China
Yingtan People's Hospital
Yingtan, Jiangxi, China
Songyuan Jilin Oilfield Hospital
Songyuan, Jilin, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
Zhongmeng Hospital of Hexigten Banner
Chifeng, Neimenggu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zongliang Li,
Role: primary
Lei Chen
Role: backup
Yuqin Deng
Role: primary
Deyan Kong, MD
Role: primary
Junfeng Shi
Role: primary
Hongtao Huo
Role: backup
Hailong Xu
Role: primary
Zhenxing Liu
Role: backup
Bo Wang
Role: primary
Bin Zhang
Role: backup
Limin Shen
Role: primary
Zhenhua Xiao
Role: primary
Shuai Zhao
Role: backup
Guangxiong Yuan
Role: primary
Junxiong Wu
Role: backup
Xiang Zeng
Role: primary
Sire Li
Role: backup
Guoyong Zeng, MD
Role: primary
Fan Zhang
Role: backup
Huashi Liu,
Role: primary
Yongfang Deng
Role: backup
Weihua Hu,
Role: primary
Jianyong Chen
Role: backup
Bin Chen
Role: primary
Qiang Li
Role: backup
Ruize Zhou
Role: primary
Xiaomei Lai
Role: backup
Yi Yin
Role: primary
Daofei Liu
Role: backup
Yan Shi
Role: primary
Qing Chen
Role: backup
Donghuan Mei
Role: primary
Hailin Yan
Role: backup
Zhiyong Xie,
Role: primary
Qingfeng Zeng
Role: backup
Hongwen Liu
Role: primary
Jiangqiang Lai
Role: backup
Fangwei Li
Role: primary
Long Gao
Role: backup
Hong Zhang
Role: primary
Xiaobin Zeng
Role: backup
Xunwei Lv,
Role: primary
Huadong Li
Role: backup
Gengxiang Xiao
Role: primary
Longshen Huang
Role: backup
Shanggui Yuan
Role: primary
Yanmao Liu
Role: backup
Xiaoyu Guan,
Role: primary
Luyang Wang
Role: backup
Hairong Hu,
Role: primary
Jian Xiao
Role: backup
Shuiping Liang
Role: primary
Xiankun Yang
Role: backup
Jinchang Tan
Role: primary
Guozhen Liu
Role: backup
Zhongbin Xia
Role: primary
Ye Liu
Role: backup
Yi Chen
Role: primary
Bin Liu
Role: primary
Wenbin Qiu
Role: backup
Wenfeng Cao
Role: primary
Zhengbing Xiang
Role: backup
Xinbo Deng
Role: primary
Ling Gao
Role: backup
Jingjing Liu
Role: primary
Tianpei Li
Role: backup
Ying Jin
Role: primary
Chunying Li
Role: backup
Zhongjun Chen
Role: primary
Manhong zhao
Role: backup
Dan Li
Role: primary
Guozhi Lu
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SecondAHGuangxiMU
Identifier Type: -
Identifier Source: org_study_id