NCT05604638RecruitingPhase 3
Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 348 (estimated)
- First submitted
- 28 Oct 2022
- Start date
- 24 Apr 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical University
- Diseases
- Stroke
- NCT number
- NCT05604638
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 348
- From 24 Apr 2024 to the primary completion date, 31 Dec 2025
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior neurological or psychiatric illness that prevents assessment of neurological function;
Other illness
- Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
- Renal insufficiency, glomerular filtration rate \< 30 mL/min;
- Allergic to tirofiban, nickel, titanium or their alloys;
- Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
- Life expectancy of any advanced disease \< 6 months;
Lab values
- 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;
Other
- 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;
- Pregnant or lactating women;
- Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
- Intracranial aneurysm, arteriovenous malformation;
- Participating in other clinical trials.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongmeng Hospital of Hexigten Banner Coordinator of this site? Confirm its status | Chifeng | China | Recruiting |
| Mingguang People's Hospital Coordinator of this site? Confirm its status | Chuzhou | China | Recruiting |
| Dalian Municipal Central Hospital Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| People's Hospital of Xunwu County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Traditional Chinese Medicine Hospital of Yudu County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| The People's Hospital of Ningdu County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Traditional Chinese Medicine Hospital of Xingguo County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Shicheng County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Anyuan County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of RuiJin City Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Shangyou County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Ganxian District Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Yudu County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Ganzhou Municipal Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Quannan County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Chongyi County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Ganzhou People's Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Second People's Hospital of Yudu County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Second Hospital of Xingguo County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Nankang TCM Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Dayu County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| People's Hospital of Xinfeng County Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Hunan Xupu Chengnan Hospital Coordinator of this site? Confirm its status | Huaihua | China | Recruiting |
| Huangmei People's Hospital Coordinator of this site? Confirm its status | Huanggang | China | Recruiting |
| People's Hospital of Wan'an county Coordinator of this site? Confirm its status | Ji’an | China | Recruiting |
| Ji'an Central People's Hospital Coordinator of this site? Confirm its status | Ji’an | China | Recruiting |
| Affiliated Hospital of Jiujiang University Coordinator of this site? Confirm its status | Jiujiang | China | Recruiting |
| Longyan People´s Hospital, Longyan City Coordinator of this site? Confirm its status | Longyan | China | Recruiting |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| The Second Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| People's Hospital Of Shaodong Coordinator of this site? Confirm its status | Shaoyang | China | Recruiting |
| Songyuan Jilin Oilfield Hospital Coordinator of this site? Confirm its status | Songyuan | China | Recruiting |
| Xiangtan Central Hospitall Coordinator of this site? Confirm its status | Xiangtan | China | Recruiting |
| Shaoshan People's Hospital Coordinator of this site? Confirm its status | Xiangtan | China | Recruiting |
| Yiling People's Hospital of Yichang city Coordinator of this site? Confirm its status | Yichang | China | Recruiting |
| People's Hospital of Yichun Coordinator of this site? Confirm its status | Yichun | China | Recruiting |
| Yingtan People's Hospital Coordinator of this site? Confirm its status | Yingtan | China | Recruiting |
| Hunan University of Medicine Affiliated Pingjiang Hospital Coordinator of this site? Confirm its status | Yueyang | China | Recruiting |
Related publications
- Intravenous Tirofiban After Tenecteplase in Acute Ischemic Stroke: The INSTANT Randomized Clinical Trial.JAMA · 2026 · PMID 42100960
This page is information, not medical advice. Discuss any trial with your doctor.