Acute Ischemic StrokePhase 4NCT07290751
Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke
A Phase 4 study testing Tirofiban in people with Acute Ischemic Stroke, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This multicenter, prospective, double-blind, placebo-controlled, randomized trial (ANGEL-DRUG2) aims to evaluate the efficacy and safety of intravenous tirofiban following intravenous thrombolysis in patients with acute ischemic stroke who show insufficient neurological improvement after initial treatment. 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
- 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
- 976 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 31 Dec 2026
- Phase
- Phase 4
- 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.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Acute ischemic stroke symptoms within 4.5 hours of last known well time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4.
- Poor neurological improvement 1 hour after intravenous thrombolysis, defined as NIHSS decrease <2 points, or neurological worsening within 1 hour, defined as NIHSS increase ≥1 point.
- Not planned for or not eligible for endovascular treatment.
- Subject or legally authorized representative can provide written informed consent.
Who cannot join
- Evidence of intracranial hemorrhage on imaging before randomization.
- Non-ischemic intracranial pathologies, such as vascular malformation, aneurysm, tumor, abscess, or demyelinating disease.
- Large or medium vessel stenosis requiring thrombectomy or intra-arterial thrombolysis.
- Contraindications to tirofiban, including but not limited to:Known hypersensitivity to tirofiban; Severe hepatic dysfunction (ALT >2× ULN or AST >2× ULN); Severe renal dysfunction (serum creatinine >1.5× ULN); Advanced heart failure (NYHA class III-IV); Coagulation disorders or history of systemic bleeding; History of thrombocytopenia or neutropenia; Prior drug-induced hematologic disease or liver dysfunction; Leukopenia (<2×10^9/L) or platelet count <100×10^9/L.
- Use of tirofiban or other GP IIb/IIIa inhibitors before randomization, or planned use of such agents after randomization.
- Definite cardioembolic source, including but not limited to: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical prosthetic heart valves, infective endocarditis, history of intracardiac thrombus, myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous left atrial echo contrast, or left ventricular ejection fraction <30%.
Show all 10Show fewer
- Pregnancy or lactation.
- Expected survival <6 months.
- Pre-existing neurological or psychiatric disorders that may interfere with outcome assessment.
- Unlikely to complete 90-day follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, 101118
About this study
Official title: Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke: A Multicenter, Prospective, Double-Blind, Placebo-Controlled, Randomized Controlled Trial
This multicenter, prospective, double-blind, placebo-controlled, randomized trial (ANGEL-DRUG2) aims to evaluate the efficacy and safety of intravenous tirofiban following intravenous thrombolysis in patients with acute ischemic stroke who show insufficient neurological improvement after initial treatment. Eligible patients (≥18 years, baseline NIHSS ≥4, within 4.5 hours from last known well) will be randomized 1:1 to receive either tirofiban or placebo infusion for 24 hours, followed by standard oral antiplatelet therapy. The primary endpoint is the proportion of patients achieving functional independence (mRS 0-2) at 90 days. Secondary outcomes include changes in NIHSS score, vessel recanalization, infarct volume, distribution of mRS scores, recurrent stroke, and health-related quality of life. Safety outcomes focus on symptomatic intracranial hemorrhage and all-cause mortality. Approximately 976 patients will be enrolled across 30 sites in China.
Read the detailed description
Acute ischemic stroke (AIS) is a leading cause of death and disability worldwide. Intravenous thrombolysis (IVT) and endovascular therapy (EVT) are guideline-recommended treatments, but many patients continue to experience unsatisfactory neurological recovery after IVT alone. Early antiplatelet therapy is recommended as adjunctive management, and tirofiban, a selective and reversible intravenous glycoprotein IIb/IIIa receptor inhibitor, has shown promise in reducing platelet aggregation and thrombus formation without significantly increasing symptomatic intracranial hemorrhage. However, robust evidence regarding its efficacy and safety in AIS patients with poor neurological improvement after IVT is lacking.
ANGEL-DRUG2 is designed to fill this knowledge gap. This trial will enroll 976 patients at 30 centers who present with acute ischemic stroke, have received IVT within 4.5 hours of onset, and demonstrate poor or worsening neurological improvement within 1 hour post-IVT (defined as NIHSS score decrease <2 or increase ≥1). Patients will be randomized in a 1:1 ratio, stratified by center, to receive either tirofiban infusion (0.4 μg/kg/min for 30 minutes, then 0.1 μg/kg/min for 23.5 hours) or placebo (normal saline) infusion of the same regimen. Both groups will be transitioned at 20 hours to standard oral antiplatelet therapy (aspirin and/or clopidogrel).
The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90±7 days. Secondary efficacy endpoints include NIHSS change at 36±12 hours, vessel recanalization on CTA/MRA, infarct volume, distribution of mRS scores at multiple timepoints, recurrent stroke within 90 days, and EQ-5D-5L quality-of-life scores. Safety endpoints include symptomatic intracranial hemorrhage within 48 hours (Heidelberg criteria), any intracranial hemorrhage, and all-cause mortality at 90 days.
This rigorously designed study will provide high-quality evidence regarding whether tirofiban, when added to IVT in AIS patients with poor early response, can improve functional outcomes without unacceptable safety risks.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban, Placebo (0.9% normal saline)
- Keywords
- stroke, tirofiban, thrombolysis
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
After intravenous thrombolysis, if neurological improvement is insufficient (NIHSS score decrease <2 within 1 hour or NIHSS increase ≥1), tirofiban infusion is initiated within 1 hour. The regimen consists of 0.4 μg/kg/min for 30 minutes, followed by 0.1 μg/kg/min for 23.5 hours (total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with tirofiban for 4 hours (bridge therapy). At 24 hours, tirofiban infusion is completed, and patients continue oral antiplatelet therapy per protocol.
Placebo (0.9% normal saline)Other
Matched normal saline infusion using the same dosing schedule and pump rates as the tirofiban arm (0.4 μg/kg/min for 30 minutes, then 0.1 μg/kg/min for 23.5 hours; total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with placebo infusion for 4 hours (bridge therapy). At 24 hours, placebo infusion is completed, and patients continue oral antiplatelet therapy per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Tirofiban | Experimental | Not described Receives: Drug: Tirofiban |
| Arm B - Placebo | Placebo comparator | Not described Receives: Other: Placebo (0.9% normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mRS 0-2 at 90 days
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
Measured: 90±7 days post-randomization
Symptomatic Intracranial Hemorrhage (sICH) within 48 hours
Heidelberg Bleeding Classification with clinical worsening criteria.
Measured: Randomization to 48 hours
Secondary outcomes (10)
Change in NIHSS from baseline to 36±12 hours
Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function
Measured: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Vascular recanalization rate assessed by CT/MR angiography
Measured: 36±12 hours post-randomization
Change in infarct volume at 7±3 days/discharge
Change in infarct volume
Measured: 7±3 days post-randomization or discharge
mRS distribution
Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
Measured: 7±3 days/discharge；90±7 days post-randomization
Proportion with mRS 0-1 at 90 days
Proportion of patients with Modified Rankin Scale (mRS) 0-1, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
Measured: 90±7 days
Proportion with mRS 0-3 at 90 days
Proportion of patients with Modified Rankin Scale (mRS) 0-3, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient
Measured: 90±7 days
Stroke recurrence at 90 ± 7 days.
Stroke recurrence
Measured: 90±7 days post-randomization
EQ-5D-5L score at 90±7 days
The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status.
Measured: 90±7 days
Any Intracranial Hemorrhage within 48 hours
Heidelberg Bleeding Classification with clinical worsening criteria.
Measured: Randomization to 48 hours
All-cause mortality at 90 days
All-cause mortality
Measured: 90±7 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 posted18 Dec 2025
- Study start11 Nov 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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 Anzhen 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 976 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochuan Huo, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290751
- Sponsor's protocol ID
- 2025-013
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hilkens NA, Casolla B, Leung TW, de Leeuw FE. Stroke. Lancet. 2024 Jun 29;403(10446):2820-2836. doi: 10.1016/S0140-6736(24)00642-1. Epub 2024 May 14.
PubMed 38759664Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
PubMed 31662037Berge E, Whiteley W, Audebert H, De Marchis GM, Fonseca AC, Padiglioni C, de la Ossa NP, Strbian D, Tsivgoulis G, Turc G. European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke. Eur Stroke J. 2021 Mar;6(1):I-LXII. doi: 10.1177/2396987321989865. Epub 2021 Feb 19.
PubMed 33817340Wang C, Yi X, Zhang B, Liao D, Lin J, Chi L. Clopidogrel plus aspirin prevents early neurologic deterioration and improves 6-month outcome in patients with acute large artery atherosclerosis stroke. Clin Appl Thromb Hemost. 2015 Jul;21(5):453-61. doi: 10.1177/1076029614551823. Epub 2014 Sep 23.
PubMed 25248816Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9.
PubMed 38196129Liu R, Liang Z, Li W, Zhan Y, Xu L, Yang S, Zheng G, Jiang L, Xie L, Sun Z, Hu Y. Adding Tirofiban on Top of Recombinant Tissue Plasminogen Activator May Improve Clinical Outcome in Acute Stroke Patients. J Stroke. 2024 Jan;26(1):121-124. doi: 10.5853/jos.2023.02250. Epub 2024 Jan 30. No abstract available.
PubMed 38326710Liang Z, Zhang J, Huang S, Yang S, Xu L, Xiang W, Zhang M. Safety and efficacy of low-dose rt-PA with tirofiban to treat acute non-cardiogenic stroke: a single-center randomized controlled study. BMC Neurol. 2022 Jul 27;22(1):280. doi: 10.1186/s12883-022-02808-w.
PubMed 35897006Yang 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 30838514Jiao Y, Wang X, Guan Y, Wang X, Li Z, Xiang X, Zhang Z. Therapeutic Efficacy of Tirofiban Combined With Thrombus Aspiration and Stent Thrombectomy in the Treatment of Large Vessel Occlusion Ischemic Stroke. Neurologist. 2025 May 1;30(3):140-144. doi: 10.1097/NRL.0000000000000603.
PubMed 39648705Zhang Y, Zhang QQ, Fu C, Wang L, Zhang GQ, Cao PW, Chen GF, Fu XM. Clinical efficacy of tirofiban combined with a Solitaire stent in treating acute ischemic stroke. Braz J Med Biol Res. 2019;52(10):e8396. doi: 10.1590/1414-431X20198396. Epub 2019 Sep 16.
PubMed 31531525Higgins JPT, Thomas J, Chandler J, et al (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook.
de Almeida Monteiro G, Leite M, Goncalves OR, Ferreira MY, Mutarelli A, Marinheiro G, Araujo B, Leal PRL, Ribeiro EML, Figueiredo EG, Telles JPM. Efficacy and safety of intravenous tirofiban combined with reperfusion therapy versus reperfusion therapy alone in acute ischemic stroke: a meta-analysis of randomized controlled trials. J Thromb Thrombolysis. 2025 Apr;58(4):526-537. doi: 10.1007/s11239-025-03094-2. Epub 2025 Apr 1.
PubMed 40167884
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Thrombolysis Combined With Tirofiban in Acute Ischemic Stroke: A Multicenter, Prospective, Double-Blind, Placebo-Controlled, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07290751
- Acronym / sponsor ID
- 2025-013
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke, tirofiban, thrombolysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 976 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
This multicenter, prospective, double-blind, placebo-controlled, randomized trial (ANGEL-DRUG2) aims to evaluate the efficacy and safety of intravenous tirofiban following intravenous thrombolysis in patients with acute ischemic stroke who show insufficient neurological improvement after initial treatment. Eligible patients (≥18 years, baseline NIHSS ≥4, within 4.5 hours from last known well) will be randomized 1:1 to receive either tirofiban or placebo infusion for 24 hours, followed by standard oral antiplatelet therapy. The primary endpoint is the proportion of patients achieving functional independence (mRS 0-2) at 90 days. Secondary outcomes include changes in NIHSS score, vessel recanalization, infarct volume, distribution of mRS scores, recurrent stroke, and health-related quality of life. Safety outcomes focus on symptomatic intracranial hemorrhage and all-cause mortality. Approximately 976 patients will be enrolled across 30 sites in China.
Detailed description
Acute ischemic stroke (AIS) is a leading cause of death and disability worldwide. Intravenous thrombolysis (IVT) and endovascular therapy (EVT) are guideline-recommended treatments, but many patients continue to experience unsatisfactory neurological recovery after IVT alone. Early antiplatelet therapy is recommended as adjunctive management, and tirofiban, a selective and reversible intravenous glycoprotein IIb/IIIa receptor inhibitor, has shown promise in reducing platelet aggregation and thrombus formation without significantly increasing symptomatic intracranial hemorrhage. However, robust evidence regarding its efficacy and safety in AIS patients with poor neurological improvement after IVT is lacking.
ANGEL-DRUG2 is designed to fill this knowledge gap. This trial will enroll 976 patients at 30 centers who present with acute ischemic stroke, have received IVT within 4.5 hours of onset, and demonstrate poor or worsening neurological improvement within 1 hour post-IVT (defined as NIHSS score decrease <2 or increase ≥1). Patients will be randomized in a 1:1 ratio, stratified by center, to receive either tirofiban infusion (0.4 μg/kg/min for 30 minutes, then 0.1 μg/kg/min for 23.5 hours) or placebo (normal saline) infusion of the same regimen. Both groups will be transitioned at 20 hours to standard oral antiplatelet therapy (aspirin and/or clopidogrel).
The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90±7 days. Secondary efficacy endpoints include NIHSS change at 36±12 hours, vessel recanalization on CTA/MRA, infarct volume, distribution of mRS scores at multiple timepoints, recurrent stroke within 90 days, and EQ-5D-5L quality-of-life scores. Safety endpoints include symptomatic intracranial hemorrhage within 48 hours (Heidelberg criteria), any intracranial hemorrhage, and all-cause mortality at 90 days.
This rigorously designed study will provide high-quality evidence regarding whether tirofiban, when added to IVT in AIS patients with poor early response, can improve functional outcomes without unacceptable safety risks.
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 |
|---|---|---|
| Arm A - Tirofiban | Experimental | Drug: Tirofiban |
| Arm B - Placebo | Placebo comparator | Other: Placebo (0.9% normal saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Acute ischemic stroke symptoms within 4.5 hours of last known well time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4.
- Poor neurological improvement 1 hour after intravenous thrombolysis, defined as NIHSS decrease <2 points, or neurological worsening within 1 hour, defined as NIHSS increase ≥1 point.
Key exclusion criteria (10 listed)
- Evidence of intracranial hemorrhage on imaging before randomization.
- Non-ischemic intracranial pathologies, such as vascular malformation, aneurysm, tumor, abscess, or demyelinating disease.
- Large or medium vessel stenosis requiring thrombectomy or intra-arterial thrombolysis.
- Contraindications to tirofiban, including but not limited to:Known hypersensitivity to tirofiban; Severe hepatic dysfunction (ALT >2× ULN or AST >2× ULN); Severe renal dysfunction (serum creatinine >1.5× ULN); Advanced heart failure (NYHA class III-IV); Coagulation disorders or history of systemic bleeding; History of thrombocytopenia or neutropenia; Prior drug-induced hematologic disease or liver dysfunction; Leukopenia (<2×10^9/L) or platelet count <100×10^9/L.
- Use of tirofiban or other GP IIb/IIIa inhibitors before randomization, or planned use of such agents after randomization.
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 |
|---|---|---|
| TirofibanAfter intravenous thrombolysis, if neurological improvement is insufficient (NIHSS score decrease <2 within 1 hour or NIHSS increase ≥1), tirofiban infusion is initiated within 1 hour. The regimen consists of 0.4 μg/kg/min for 30 minutes, followed by 0.1 μg/kg/min for 23.5 hours (total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with tirofiban for 4 hours (bridge therapy). At 24 hours, tirofiban infusion is completed, and patients continue oral antiplatelet therapy per protocol. | Drug | Arm A - Tirofiban |
| Placebo (0.9% normal saline)Matched normal saline infusion using the same dosing schedule and pump rates as the tirofiban arm (0.4 μg/kg/min for 30 minutes, then 0.1 μg/kg/min for 23.5 hours; total 24 hours). At the 20th hour of infusion, oral antiplatelet therapy (aspirin 100 mg once daily and/or clopidogrel 75 mg once daily) is initiated, overlapping with placebo infusion for 4 hours (bridge therapy). At 24 hours, placebo infusion is completed, and patients continue oral antiplatelet therapy per protocol. | Other | Arm B - Placebo |
Primary outcome
Proportion of patients with mRS 0-2 at 90 days
Time frame: 90±7 days post-randomization
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
Symptomatic Intracranial Hemorrhage (sICH) within 48 hours
Time frame: Randomization to 48 hours
Heidelberg Bleeding Classification with clinical worsening criteria.
10 secondary outcomes
Change in NIHSS from baseline to 36±12 hours
Time frame: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Time frame: 36±12 hours post-randomization
Change in infarct volume at 7±3 days/discharge
Time frame: 7±3 days post-randomization or discharge
mRS distribution
Time frame: 7±3 days/discharge；90±7 days post-randomization
Proportion with mRS 0-1 at 90 days
Time frame: 90±7 days
Proportion with mRS 0-3 at 90 days
Time frame: 90±7 days
Stroke recurrence at 90 ± 7 days.
Time frame: 90±7 days post-randomization
EQ-5D-5L score at 90±7 days
Time frame: 90±7 days
Any Intracranial Hemorrhage within 48 hours
Time frame: Randomization to 48 hours
All-cause mortality at 90 days
Time frame: 90±7 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 23 Dec 2025.
- Background: PubMed 38759664Hilkens NA, Casolla B, Leung TW, de Leeuw FE. Stroke. Lancet. 2024 Jun 29;403(10446):2820-2836. doi: 10.1016/S0140-6736(24)00642-1. Epub 2024 May 14.
- Background: PubMed 31662037Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
- Background: PubMed 33817340Berge E, Whiteley W, Audebert H, De Marchis GM, Fonseca AC, Padiglioni C, de la Ossa NP, Strbian D, Tsivgoulis G, Turc G. European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke. Eur Stroke J. 2021 Mar;6(1):I-LXII. doi: 10.1177/2396987321989865. Epub 2021 Feb 19.
- Background: PubMed 25248816Wang C, Yi X, Zhang B, Liao D, Lin J, Chi L. Clopidogrel plus aspirin prevents early neurologic deterioration and improves 6-month outcome in patients with acute large artery atherosclerosis stroke. Clin Appl Thromb Hemost. 2015 Jul;21(5):453-61. doi: 10.1177/1076029614551823. Epub 2014 Sep 23.
- Background: PubMed 38196129Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9.
- Background: PubMed 38326710Liu R, Liang Z, Li W, Zhan Y, Xu L, Yang S, Zheng G, Jiang L, Xie L, Sun Z, Hu Y. Adding Tirofiban on Top of Recombinant Tissue Plasminogen Activator May Improve Clinical Outcome in Acute Stroke Patients. J Stroke. 2024 Jan;26(1):121-124. doi: 10.5853/jos.2023.02250. Epub 2024 Jan 30. No abstract available.
- Background: PubMed 35897006Liang Z, Zhang J, Huang S, Yang S, Xu L, Xiang W, Zhang M. Safety and efficacy of low-dose rt-PA with tirofiban to treat acute non-cardiogenic stroke: a single-center randomized controlled study. BMC Neurol. 2022 Jul 27;22(1):280. doi: 10.1186/s12883-022-02808-w.
- Background: PubMed 30838514Yang 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.
- Background: PubMed 39648705Jiao Y, Wang X, Guan Y, Wang X, Li Z, Xiang X, Zhang Z. Therapeutic Efficacy of Tirofiban Combined With Thrombus Aspiration and Stent Thrombectomy in the Treatment of Large Vessel Occlusion Ischemic Stroke. Neurologist. 2025 May 1;30(3):140-144. doi: 10.1097/NRL.0000000000000603.
- Background: PubMed 31531525Zhang Y, Zhang QQ, Fu C, Wang L, Zhang GQ, Cao PW, Chen GF, Fu XM. Clinical efficacy of tirofiban combined with a Solitaire stent in treating acute ischemic stroke. Braz J Med Biol Res. 2019;52(10):e8396. doi: 10.1590/1414-431X20198396. Epub 2019 Sep 16.
- BackgroundHiggins JPT, Thomas J, Chandler J, et al (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook.
- Background: PubMed 40167884de Almeida Monteiro G, Leite M, Goncalves OR, Ferreira MY, Mutarelli A, Marinheiro G, Araujo B, Leal PRL, Ribeiro EML, Figueiredo EG, Telles JPM. Efficacy and safety of intravenous tirofiban combined with reperfusion therapy versus reperfusion therapy alone in acute ischemic stroke: a meta-analysis of randomized controlled trials. J Thromb Thrombolysis. 2025 Apr;58(4):526-537. doi: 10.1007/s11239-025-03094-2. Epub 2025 Apr 1.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirofiban in people with Acute Ischemic Stroke, run by Beijing Anzhen 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 7 inclusion and 10 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 23 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xiaochuan Huo (+8613716292262, huoxiaochuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with mRS 0-2 at 90 days (time frame: 90±7 days post-randomization). 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 NCT07290751, which also lists 12 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 23 Dec 2025.