Acute Ischemic StrokePhase 3RESCUE-ASNCT07335107

Intravenous Tirofiban After Bridging Therapy for Acute Stroke With Atherosclerotic Large Artery Occlusion

A Phase 3 study testing Intravenous Tirofiban and Standard Medical Therapy in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Ischemic Stroke
What is being tested?: Intravenous Tirofiban and Standard Medical Therapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 564 participants
Where: 1 siteChina
Study dates: 12 Jan 2026to 30 Apr 2027
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.
Pre-mRS 0-2.
Baseline NIHSS 6-30 points.
Baseline ASPECTS ≥6 points.
Baseline CTA/MRA diagnosed: the ICA or MCA-M1/M2 occlusion.
Receiving bridging therapy (EVT following IV Tenecteplase) within 24 hours from stroke onset.

Show all 10Show fewer

Baseline DSA diagnosed: ICAD related LVO.
ICAD-related LVO is assumed if any one the following criteria is fulfilled: (1) absence of atrial fibrillation; (2) truncal-type occlusion; (3) residual stenosis ≥30% on DSA after the first retriever; (4) researchers determined it to be ICAD-related LVO based on the TOAST classification.
Patients have achieved successful reperfusion after EVT (mTICI ≥2b).
Patients or their eligible surrogates provided informed consent.

Who cannot join

Previously known permanent, persistent, or paroxysmal atrial fibrillation.
Permanent stenting during EVT;
Patient had severe bleeding or the following conditions, such as active gastrointestinal ulcer, aortic dissection, platelet count <100 ×109/L, hemoglobin <100 g/L, INR≥1.7 in the last 6 months.
Contraindication to glycoprotein IIb/IIIa inhibitors.
Imaging examination (Flat-panel NCCT/DCT) before randomization showed the following: Heidelberg hemorrhage type 1c, 2, or 3 ICH with or without clinical exacerbation (an increase of ≥4 points in the NIHSS score from baseline or an increase of ≥2 points in any of the NIHSS scores or resulting in intubation, decompression of bone valves, ventricular drainage, or other significant medical/surgical intervention), infarct area greater than 50% of the middle cerebral artery blood supply area or infarct volume ≥70ml, cerebral hernia signs.
Vascular malformations, arterial dissection, intracranial aneurysms, tumors (except for small meningiomas), cerebrovascular inflammation, cerebral amyloid angiopathy, or other major non-ischemic craniocerebral diseases (e.g. multiple sclerosis) as diagnosed by head imaging.

Show all 14Show fewer

Acute renal failure, dialysis, or estimated glomerular filtration rate (eGFR) < 30ml/min/1.72m2, or serum creatinine > 220mmol/L (2.5mg/dl).
History of severe liver disease, or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or glutamyltransferase (GGT) ≥3×ULN and/or total bilirubin (TBIL) ≥2×ULN.
Acute ST elevation myocardial infarction (MI), acute decompensated heart failure, QTc>500 ms, hospitalization or involuntary coronary intervention due to acute coronary syndrome, MI, cardiac arrest within the past 3 months.
Severe non-cardiovascular comorbidity with life expectancy < 3 months (e.g., malignant tumors).
Any clinical conditions determined by the study team that may limit adherence to the study process.
Currently receiving an investigational drug or device.
Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test.
The subject's informed consent was not obtained.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liping Liu contact

+86-010-59978328

lipingsister@gmail.com

China1 site

Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: Intravenous Tirofiban After Bridging Therapy for Acute Stroke With Atherosclerotic Large Artery Occlusion (RESCUE-AS): A Multicenter, Randomized, Open Label, Blinded Endpoint Study

The investigators propose to assess the efficacy and safety of intravenous tirofiban after bridging therapy (endovascular therapy [EVT] following intravenous Tenecteplase) for acute ischemic stroke due to intracranial atherosclerotic disease related large vessel occlusion (ICAD related LVO). This study will recruit 564 patients from about 50 hospitals in China. Inclusion criteria for the trial are: (1)age ≥18 years old, (2)Pre-mRS 0-2, (3)Baseline NIHSS 6-30 points, (4) Baseline ASPECTS ≥6 points, (5) Baseline CTA/MRA diagnosed: the ICA or MCA-M1/M2 occlusion, (6) Receiving bridging therapy (EVT following IV Tenecteplase) within 24 hours from stroke onset (7) Baseline DSA diagnosed: ICAD related LVO(if any one the following criteria is fulfilled: 1) absence of atrial fibrillation; 2) truncal-type occlusion; 3) residual stenosis ≥30% on DSA after the first retriever; 4) researchers determined it to be ICAD-related LVO based on the TOAST classification, (8) Have achieved successful reperfusion after EVT (mTICI ≥2b). Patients with previously known permanent, persistent, or paroxysmal atrial fibrillation, permanent stenting during EVT, severe bleeding or had a higher bleeding risk in the last 6 months, imaging examination before randomization showed the Heidelberg hemorrhage type 1c, 2, or 3 ICH with or without clinical exacerbation, infarct area greater than 50% of the middle cerebral artery blood supply area or infarct volume ≥70ml, cerebral hernia signs, and some other severe organic diseases and an expected survival time of less than 90 days, severe liver insufficiency or renal insufficiency will be excluded. Patients will be randomly assigned to the experimental group or control group at a 1:1 ratio. Experimental group will receive intravenous tirofiban of a dose of 0.4 μg/kilo/min for 30 minutes after the completion of bridging therapy, followed by a continuous infusion of 0.1 μg/kilo/min for up to 24 hours. Then the patient will transition to standard medical therapy, with no restrictions on the antiplatelet regimen but is advised to receive loading dose dual antiplatelet therapy (oral aspirin 100 mg and clopidogrel 300 mg four hours before the end of intravenous tirofiban and daily oral aspirin 100 mg and clopidogrel 75 mg for 30 days). Control group will receive standard medical therapy after bridging treatment. The primary endpoint is the proportion of modified Rankin Scale (mRS) score 0 to 2 at 90±7 days after onset. The primary safety outcome is the symptomatic intracerebral hemorrhage (sICH) within 48 hours after randomization according to ECASS III criteria. This trial will provide important information for the standardization of antiplatelet medication regimens after bridging therapy for improving functional outcomes in patients with acute large vessel atherosclerotic occlusive ischemic stroke.

Conditions: Acute Ischemic Stroke
Being tested: Intravenous Tirofiban, Standard Medical Therapy
Keywords: Acute ischemic stroke, Tirofiban, Large vessel occlusion, Intracranial atherosclerotic disease, bridging treatment
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous TirofibanDrug
Intravenous infusion of tirofiban within 5 minutes after randomization at a dose of 0.4 μg/kg/min for 30 minutes, followed by maintenance infusion via an intravenous microinfusion pump at 0.1 μg/kg/min for 23.5 hours (if tirofiban has already been administered intraoperatively, a continuous intravenous microinfusion pump at 0.1 μg/kg/min will be started directly postoperatively and continued for 24 hours). Tirofiban will be discontinued at 24 hours.
Standard Medical TherapyDrug
standard medical therapy after randomization. The antiplatelet regimen is not restricted.

Study groups in NCT07335107
Study group	Role	What they receive
Tirofiban Group	Experimental	Not described Receives: Drug: Intravenous Tirofiban
Control Group	Active comparator	Not described Receives: Drug: Standard Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

the proportion of mRS score 0 to 2
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance.
Measured: at 90±7 days after onset
symptomatic intracerebral hemorrhage according to ECASS III criteria
Measured: within 48 hours after randomization

Secondary outcomes (8)

Ordinal mRS score
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance; 4 indicating moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance; 5 indicating severe disability: bedridden, incontinent, and requiring constant nursing care and attention; and 6 indicating death.
Measured: at 90±7 days after onset
mRS score 0 to 1
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities.
Measured: at 90±7 days after onset
mRS score 0 to 3
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance.
Measured: at 90±7 days after onset
Early reocclusion
Measured: within 48±12 hours after randomization
Severe bleeding according to GUSTO criteria
Measured: within 48±12 hours after randomization
Early neurological deterioration (increase in NIHSS score ≥4 points within 72 hours after randomization)
Measured: within 72±12 hours after randomization
Any intracerebral hemorrhage
Measured: within 48±12 hours after randomization
Mortality
Measured: within 90 days after onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202630 Apr 2027

First posted12 Jan 2026
Study start12 Jan 2026 (estimated)
Primary completion31 Jan 2027 (estimated)
Study completion30 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
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
Model description: Patients will be randomly assigned to the experimental group or control group at a 1:1 ratio. Experimental group: will receive intravenous infusion of tirofiban within 5 minutes after randomization at a dose of 0.4 μg/kg/min for 30 minutes, followed by maintenance infusion via an intravenous microinfusion pump at 0.1 μg/kg/min for 23.5 hours (if tirofiban has already been administered intraoperatively, a continuous intravenous microinfusion pump at 0.1 μg/kg/min will be started directly postoperatively and continued for 24 hours). Tirofiban will be discontinued at 24 hours. Control group: will receive standard medical therapy after bridging treatment.
Masking: None (open label)
Enrolment: 564 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07335107
Sponsor's protocol ID: RESCUE-AS
Acronym: RESCUE-AS
Status last verified: Jan 2026
First submitted: 5 Jan 2026
Last updated: 13 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is not a plan to make IPD available. Sharing IPD will require IRB approval from Tiantan Hospital and other participating institutes in China.

Publications

Zhao W, Che R, Shang S, Wu C, Li C, Wu L, Chen J, Duan J, Song H, Zhang H, Ling F, Wang Y, Liebeskind D, Feng W, Ji X. Low-Dose Tirofiban Improves Functional Outcome in Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy. Stroke. 2017 Dec;48(12):3289-3294. doi: 10.1161/STROKEAHA.117.019193. Epub 2017 Nov 10.
PubMed 29127270
Kellert L, Hametner C, Rohde S, Bendszus M, Hacke W, Ringleb P, Stampfl S. Endovascular stroke therapy: tirofiban is associated with risk of fatal intracerebral hemorrhage and poor outcome. Stroke. 2013 May;44(5):1453-5. doi: 10.1161/STROKEAHA.111.000502. Epub 2013 Mar 5.
PubMed 23463755
Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.
PubMed 37256974
RESCUE BT Trial Investigators; Qiu Z, Li F, Sang H, Luo W, Liu S, Liu W, Guo Z, Li H, Sun D, Huang W, Zhang M, Zhang M, Dai W, Zhou P, Deng W, Zhou Z, Huang X, Lei B, Li J, Yuan Z, Song B, Miao J, Liu S, Jin Z, Zeng G, Zeng H, Yuan J, Wen C, Yu Y, Yuan G, Wu J, Long C, Luo J, Tian Z, Zheng C, Hu Z, Wang S, Wang T, Qi L, Li R, Wan Y, Ke Y, Wu Y, Zhu X, Kong W, Huang J, Peng D, Chang M, Ge H, Shi Z, Yan Z, Du J, Jin Y, Ju D, Huang C, Hong Y, Liu T, Zhao W, Wang J, Zheng B, Wang L, Liu S, Luo X, Luo S, Xu X, Hu J, Pu J, Chen S, Sun Y, Jiang S, Wei L, Fu X, Bai Y, Yang S, Hu W, Zhang G, Pan C, Zhang S, Wang Y, Cao W, Yang S, Zhang J, Guo F, Wen H, Zhang J, Song J, Yue C, Li L, Wu D, Tian Y, Yang J, Lu M, Saver JL, Nogueira RG, Zi W, Yang Q. Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial. JAMA. 2022 Aug 9;328(6):543-553. doi: 10.1001/jama.2022.12584.
PubMed 35943471
Baek BH, Yoon W, Lee YY, Kim SK, Kim JT, Park MS. Intravenous Tirofiban Infusion After Angioplasty and Stenting in Intracranial Atherosclerotic Stenosis-Related Stroke. Stroke. 2021 May;52(5):1601-1608. doi: 10.1161/STROKEAHA.120.033551. Epub 2021 Apr 1.
PubMed 33793319
Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.
PubMed 31570084
Gao F, Tong X, Jia B, Wei M, Pan Y, Yang M, Sun D, Nguyen TN, Ren Z, Demiraj F, Yao X, Xu C, Yuan G, Wan Y, Tang J, Wang J, Jiang Y, Wang C, Luo X, Yang H, Shen R, Wu Z, Yuan Z, Wan D, Hu W, Liu Y, Jing P, Wei L, Zheng T, Wu Y, Yang X, Sun Y, Wen C, Chang M, Yin B, Li D, Duan J, Sun D, Guo Z, Xu G, Wang G, Wang L, Wang Y, Jia W, Ma G, Huo X, Mo D, Ma N, Liu L, Zhao X, Wang Y, Fiehler J, Wang Y, Miao Z. Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet Neurol. 2024 Aug;23(8):797-806. doi: 10.1016/S1474-4422(24)00186-8. Epub 2024 Jun 21.
PubMed 38914085
Yang X, Sun D, Huo X, Raynald R, Jia B, Tong X, Wang A, Ma N, Gao F, Mo D, Miao Z; ANGEL-ACT study group. Futile reperfusion of endovascular treatment for acute anterior circulation large vessel occlusion in the ANGEL-ACT registry. J Neurointerv Surg. 2023 Dec 21;15(e3):e363-e368. doi: 10.1136/jnis-2022-019874.
PubMed 36693725
Zhou T, Yi T, Li T, Zhu L, Li Y, Li Z, Wang M, Li Q, He Y, Yang P, Zhang Y, Li Z, Zhang Y, Ye X, Chen W, Wang S, Liu J; DIRECT-MT Registry Investigators. Predictors of futile recanalization in patients undergoing endovascular treatment in the DIRECT-MT trial. J Neurointerv Surg. 2022 Aug;14(8):752-755. doi: 10.1136/neurintsurg-2021-017765. Epub 2021 Sep 2.
PubMed 34475255
Ma Q, Li R, Wang L, Yin P, Wang Y, Yan C, Ren Y, Qian Z, Vaughn MG, McMillin SE, Hay SI, Naghavi M, Cai M, Wang C, Zhang Z, Zhou M, Lin H, Yang Y. Temporal trend and attributable risk factors of stroke burden in China, 1990-2019: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2021 Dec;6(12):e897-e906. doi: 10.1016/S2468-2667(21)00228-0.
PubMed 34838196
GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PubMed 34487721
Fu Z, Xu C, Liu X, Wang Z, Gao L. Safety and Efficacy of Tirofiban in Acute Ischemic Stroke Patients Receiving Endovascular Treatment: A Meta-Analysis. Cerebrovasc Dis. 2020;49(4):442-450. doi: 10.1159/000509054. Epub 2020 Jul 30.
PubMed 32731250
Sang H, Xie D, Tian Y, Nguyen TN, Saver JL, Nogueira RG, Wu J, Long C, Tian Z, Hu Z, Wang T, Li R, Ke Y, Zhu X, Peng D, Chang M, Li L, Ruan J, Wu D, Zi W, Yang Q, Li F, Qiu Z. Association of Tirofiban With Functional Outcomes After Thrombectomy in Acute Ischemic Stroke Due to Intracranial Atherosclerotic Disease. Neurology. 2023 May 9;100(19):e1996-e2006. doi: 10.1212/WNL.0000000000207194. Epub 2023 Mar 20.
PubMed 36941074
Yang M, Huo X, Miao Z, Wang Y. Platelet Glycoprotein IIb/IIIa Receptor Inhibitor Tirofiban in Acute Ischemic Stroke. Drugs. 2019 Apr;79(5):515-529. doi: 10.1007/s40265-019-01078-0.
PubMed 30838514
Jovin TG, Nogueira RG, Lansberg MG, Demchuk AM, Martins SO, Mocco J, Ribo M, Jadhav AP, Ortega-Gutierrez S, Hill MD, Lima FO, Haussen DC, Brown S, Goyal M, Siddiqui AH, Heit JJ, Menon BK, Kemp S, Budzik R, Urra X, Marks MP, Costalat V, Liebeskind DS, Albers GW. Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis. Lancet. 2022 Jan 15;399(10321):249-258. doi: 10.1016/S0140-6736(21)01341-6. Epub 2021 Nov 11.
PubMed 34774198

Interested in taking part?

Liping Liu

+86-010-59978328

lipingsister@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravenous Tirofiban After Bridging Therapy for Acute Stroke With Atherosclerotic Large Artery Occlusion (RESCUE-AS): A Multicenter, Randomized, Open Label, Blinded Endpoint Study
ClinicalTrials.gov ID: NCT07335107
Acronym / sponsor ID: RESCUE-AS / RESCUE-AS
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke, Tirofiban, Large vessel occlusion, Intracranial atherosclerotic disease, bridging treatment
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 564 participants (estimated)
Lead sponsor: Beijing Tiantan HospitalUniversity, hospital or other
Study start: 12 Jan 2026 (estimated)
Primary completion: 31 Jan 2027 (estimated)
Study completion: 30 Apr 2027 (estimated)
First posted: 12 Jan 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients will be randomly assigned to the experimental group or control group at a 1:1 ratio. Experimental group: will receive intravenous infusion of tirofiban within 5 minutes after randomization at a dose of 0.4 μg/kg/min for 30 minutes, followed by maintenance infusion via an intravenous microinfusion pump at 0.1 μg/kg/min for 23.5 hours (if tirofiban has already been administered intraoperatively, a continuous intravenous microinfusion pump at 0.1 μg/kg/min will be started directly postoperatively and continued for 24 hours). Tirofiban will be discontinued at 24 hours. Control group: will receive standard medical therapy after bridging treatment.

Arm	Type	Receives
Tirofiban Group	Experimental	Drug: Intravenous Tirofiban
Control Group	Active comparator	Drug: Standard Medical Therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age ≥18 years old.
Pre-mRS 0-2.
Baseline NIHSS 6-30 points.
Baseline ASPECTS ≥6 points.
Baseline CTA/MRA diagnosed: the ICA or MCA-M1/M2 occlusion.

Key exclusion criteria (14 listed)

Previously known permanent, persistent, or paroxysmal atrial fibrillation.
Permanent stenting during EVT;
Patient had severe bleeding or the following conditions, such as active gastrointestinal ulcer, aortic dissection, platelet count <100 ×109/L, hemoglobin <100 g/L, INR≥1.7 in the last 6 months.
Contraindication to glycoprotein IIb/IIIa inhibitors.
Imaging examination (Flat-panel NCCT/DCT) before randomization showed the following: Heidelberg hemorrhage type 1c, 2, or 3 ICH with or without clinical exacerbation (an increase of ≥4 points in the NIHSS score from baseline or an increase of ≥2 points in any of the NIHSS scores or resulting in intubation, decompression of bone valves, ventricular drainage, or other significant medical/surgical intervention), infarct area greater than 50% of the middle cerebral artery blood supply area or infarct volume ≥70ml, cerebral hernia signs.

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
Intravenous TirofibanIntravenous infusion of tirofiban within 5 minutes after randomization at a dose of 0.4 μg/kg/min for 30 minutes, followed by maintenance infusion via an intravenous microinfusion pump at 0.1 μg/kg/min for 23.5 hours (if tirofiban has already been administered intraoperatively, a continuous intravenous microinfusion pump at 0.1 μg/kg/min will be started directly postoperatively and continued for 24 hours). Tirofiban will be discontinued at 24 hours.	Drug	Tirofiban Group
Standard Medical Therapystandard medical therapy after randomization. The antiplatelet regimen is not restricted.	Drug	Control Group

Primary outcome

the proportion of mRS score 0 to 2
Time frame: at 90±7 days after onset
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance.
symptomatic intracerebral hemorrhage according to ECASS III criteria
Time frame: within 48 hours after randomization

8 secondary outcomes

Ordinal mRS score
Time frame: at 90±7 days after onset
mRS score 0 to 1
Time frame: at 90±7 days after onset
mRS score 0 to 3
Time frame: at 90±7 days after onset
Early reocclusion
Time frame: within 48±12 hours after randomization
Severe bleeding according to GUSTO criteria
Time frame: within 48±12 hours after randomization
Early neurological deterioration (increase in NIHSS score ≥4 points within 72 hours after randomization)
Time frame: within 72±12 hours after randomization
Any intracerebral hemorrhage
Time frame: within 48±12 hours after randomization
Mortality
Time frame: within 90 days after onset

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 13 Jan 2026.
Results publication: PubMed 29127270Zhao W, Che R, Shang S, Wu C, Li C, Wu L, Chen J, Duan J, Song H, Zhang H, Ling F, Wang Y, Liebeskind D, Feng W, Ji X. Low-Dose Tirofiban Improves Functional Outcome in Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy. Stroke. 2017 Dec;48(12):3289-3294. doi: 10.1161/STROKEAHA.117.019193. Epub 2017 Nov 10.
Results publication: PubMed 23463755Kellert L, Hametner C, Rohde S, Bendszus M, Hacke W, Ringleb P, Stampfl S. Endovascular stroke therapy: tirofiban is associated with risk of fatal intracerebral hemorrhage and poor outcome. Stroke. 2013 May;44(5):1453-5. doi: 10.1161/STROKEAHA.111.000502. Epub 2013 Mar 5.
Results publication: PubMed 37256974Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.
Results publication: PubMed 35943471RESCUE BT Trial Investigators; Qiu Z, Li F, Sang H, Luo W, Liu S, Liu W, Guo Z, Li H, Sun D, Huang W, Zhang M, Zhang M, Dai W, Zhou P, Deng W, Zhou Z, Huang X, Lei B, Li J, Yuan Z, Song B, Miao J, Liu S, Jin Z, Zeng G, Zeng H, Yuan J, Wen C, Yu Y, Yuan G, Wu J, Long C, Luo J, Tian Z, Zheng C, Hu Z, Wang S, Wang T, Qi L, Li R, Wan Y, Ke Y, Wu Y, Zhu X, Kong W, Huang J, Peng D, Chang M, Ge H, Shi Z, Yan Z, Du J, Jin Y, Ju D, Huang C, Hong Y, Liu T, Zhao W, Wang J, Zheng B, Wang L, Liu S, Luo X, Luo S, Xu X, Hu J, Pu J, Chen S, Sun Y, Jiang S, Wei L, Fu X, Bai Y, Yang S, Hu W, Zhang G, Pan C, Zhang S, Wang Y, Cao W, Yang S, Zhang J, Guo F, Wen H, Zhang J, Song J, Yue C, Li L, Wu D, Tian Y, Yang J, Lu M, Saver JL, Nogueira RG, Zi W, Yang Q. Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial. JAMA. 2022 Aug 9;328(6):543-553. doi: 10.1001/jama.2022.12584.
Results publication: PubMed 33793319Baek BH, Yoon W, Lee YY, Kim SK, Kim JT, Park MS. Intravenous Tirofiban Infusion After Angioplasty and Stenting in Intracranial Atherosclerotic Stenosis-Related Stroke. Stroke. 2021 May;52(5):1601-1608. doi: 10.1161/STROKEAHA.120.033551. Epub 2021 Apr 1.
Results publication: PubMed 31570084Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.
Results publication: PubMed 38914085Gao F, Tong X, Jia B, Wei M, Pan Y, Yang M, Sun D, Nguyen TN, Ren Z, Demiraj F, Yao X, Xu C, Yuan G, Wan Y, Tang J, Wang J, Jiang Y, Wang C, Luo X, Yang H, Shen R, Wu Z, Yuan Z, Wan D, Hu W, Liu Y, Jing P, Wei L, Zheng T, Wu Y, Yang X, Sun Y, Wen C, Chang M, Yin B, Li D, Duan J, Sun D, Guo Z, Xu G, Wang G, Wang L, Wang Y, Jia W, Ma G, Huo X, Mo D, Ma N, Liu L, Zhao X, Wang Y, Fiehler J, Wang Y, Miao Z. Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet Neurol. 2024 Aug;23(8):797-806. doi: 10.1016/S1474-4422(24)00186-8. Epub 2024 Jun 21.
Results publication: PubMed 36693725Yang X, Sun D, Huo X, Raynald R, Jia B, Tong X, Wang A, Ma N, Gao F, Mo D, Miao Z; ANGEL-ACT study group. Futile reperfusion of endovascular treatment for acute anterior circulation large vessel occlusion in the ANGEL-ACT registry. J Neurointerv Surg. 2023 Dec 21;15(e3):e363-e368. doi: 10.1136/jnis-2022-019874.
Results publication: PubMed 34475255Zhou T, Yi T, Li T, Zhu L, Li Y, Li Z, Wang M, Li Q, He Y, Yang P, Zhang Y, Li Z, Zhang Y, Ye X, Chen W, Wang S, Liu J; DIRECT-MT Registry Investigators. Predictors of futile recanalization in patients undergoing endovascular treatment in the DIRECT-MT trial. J Neurointerv Surg. 2022 Aug;14(8):752-755. doi: 10.1136/neurintsurg-2021-017765. Epub 2021 Sep 2.
Results publication: PubMed 34838196Ma Q, Li R, Wang L, Yin P, Wang Y, Yan C, Ren Y, Qian Z, Vaughn MG, McMillin SE, Hay SI, Naghavi M, Cai M, Wang C, Zhang Z, Zhou M, Lin H, Yang Y. Temporal trend and attributable risk factors of stroke burden in China, 1990-2019: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2021 Dec;6(12):e897-e906. doi: 10.1016/S2468-2667(21)00228-0.
Results publication: PubMed 34487721GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
Results publication: PubMed 32731250Fu Z, Xu C, Liu X, Wang Z, Gao L. Safety and Efficacy of Tirofiban in Acute Ischemic Stroke Patients Receiving Endovascular Treatment: A Meta-Analysis. Cerebrovasc Dis. 2020;49(4):442-450. doi: 10.1159/000509054. Epub 2020 Jul 30.
Individual participant dataSharing planned: No. There is not a plan to make IPD available. Sharing IPD will require IRB approval from Tiantan Hospital and other participating institutes in China.

Related trials for Acute Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

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.

Liping Liu contact

+86-010-59978328

lipingsister@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous Tirofiban and Standard Medical Therapy in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site 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 10 inclusion and 14 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 Liping Liu (+86-010-59978328, lipingsister@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the proportion of mRS score 0 to 2 (time frame: at 90±7 days after onset). The study lists 2 primary outcomes in all. 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 NCT07335107, which also lists 18 linked publications.

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 13 Jan 2026.