Acute Ischemic StrokePhase 3E-TWISTNCT07347626
Eptifibatide for Extended Window Ischemic Stroke After Thrombolysis
A Phase 3 study testing Eptifibatide (Integrilin) and Standard Medical Therapy in people with Acute Ischemic Stroke, run by Xinqiao Hospital of Chongqing at 6 sites in China.
Trial summary
This is a multicenter, randomized, open-label, blinded-endpoint clinical trial designed to evaluate the efficacy and safety of early administration of eptifibatide following intravenous thrombolysis in patients with acute ischemic stroke who present 4.5 to 24 hours after symptom onset. 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?
- Eptifibatide (Integrilin) and Standard Medical Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 6 sitesChina
- Study dates
- 1 Mar 2026to 31 Dec 2029
- 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.
- Acute ischemic stroke, with the time interval from last known well to hospital presentation being 4.5 to 24 hours.
- NIHSS score ≥ 4 before randomization; if large or medium vessel occlusion is present, an NIHSS score ≤ 10 is also required.
- Presence of any of the following conditions after completion of standard intravenous thrombolysis:
- No significant neurological improvement within 1 hour (defined as a change in NIHSS score ≤ 1 point from baseline).
- Early neurological deterioration within 1 hour of onset (defined as an increase in NIHSS score ≥ 2 points from baseline).
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- Neurological fluctuation within 24 hours after symptom onset (defined as an increase in NIHSS score ≥ 2 points from the lowest value post-thrombolysis).
- Ability to receive the assigned study drug within 60 minutes after intravenous thrombolysis.
- Signed written informed consent obtained from the patient or their legal representative.
Who cannot join
- Intracranial hemorrhage confirmed by CT or MRI.
- Planned endovascular therapy.
- Presence of any definite cardioembolic source, including: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous echo contrast in the left atrium, or ejection fraction < 30%.
- Pre-stroke modified Rankin Scale (mRS) score ≥ 2.
- Renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 μmol/L [2.5 mg/dL]).
- Known hypercoagulable state.
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- Platelet count < 100 × 10⁹/L.
- Pregnancy or lactation.
- Allergy to eptifibatide, other glycoprotein IIb/IIIa inhibitors, aspirin, or clopidogrel.
- History of non-atherosclerotic arteriopathy, including moyamoya disease, arterial dissection, or fibromuscular dysplasia.
- Pre-existing neurological or psychiatric disease that would preclude accurate neurological assessment.
- History of bleeding diathesis, severe cardiac disease, liver disease, or sepsis.
- Brain tumor with mass effect on imaging (except for small meningiomas).
- Evidence of intracranial arteriovenous malformation or aneurysm with diameter > 5 mm on CT or MR angiography.
- Current participation in another clinical trial.
- Any terminal illness with life expectancy < 6 months.
- Anticipated inability to complete follow-up.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Xinqiao Hospital and The Second Affiliated Hospital
Chongqing, Chongqing Municipality, 400000
Zhongming Qiu, +86 13236599269, qiuzhongmingdoctor@163.com
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000
Guoyong Zeng, +86 13507079530, hsyygy@163.com
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
Qiujiang Xi, +86 18170868978, Xiqiujiang992437@sina.com
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570100
Zhenqiang Zhao, +86 13976015677, zhenqiang.zhao@qq.com
The Affiliated Hospital of Jinggangshan University
Ji’an, Jiangxi, 343000
Yongcheng Zhang, +86 13970656839, 2378666511@qq.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Daojun Hong, MD, +86 13879187691, hongdaojun@hotmail.com
About this study
Official title: Efficacy and Safety of Eptifibatide Therapy Following Intravenous Thrombolysis in Acute Ischemic Stroke Patients Within 4.5 to 24 Hours After Onset: A Multicenter, Randomized Controlled Trial
This is a multicenter, randomized, open-label, blinded-endpoint clinical trial designed to evaluate the efficacy and safety of early administration of eptifibatide following intravenous thrombolysis in patients with acute ischemic stroke who present 4.5 to 24 hours after symptom onset.
Read the detailed description
Several clinical trials (e.g., TRACE-3, EXPECTS, HOPE) have successfully extended the time window for intravenous thrombolysis (IVT) from the conventional 4.5 hours up to 24 hours after symptom onset by utilizing advanced imaging selection techniques. Consequently, the 2024 Chinese guidelines for reperfusion therapy recommend IVT for patients presenting 4.5 to 24 hours after onset, based on imaging selection criteria. However, clinical practice indicates that a considerable proportion of patients exhibit suboptimal recanalization outcomes or even experience early neurological deterioration (END) despite receiving standard IVT. Previous research, such as the ASSET-IT trial, has primarily focused on patients treated within 4.5 hours of onset. For the growing population of "extended-window" (4.5-24 hours) patients receiving IVT facilitated by advances in imaging, the optimal antiplatelet strategy following thrombolysis remains an area with no high-level evidence. Therefore, this study aims to evaluate the efficacy and safety of early administration of eptifibatide following standard IVT (with tenecteplase or alteplase) in patients with acute ischemic stroke who present 4.5 to 24 hours after symptom onset. Patients who have received standard IVT but exhibit early neurological deterioration, fluctuation, or lack of significant improvement within 1 hour post-thrombolysis will be randomized 1:1 to receive either eptifibatide (a single intravenous bolus followed by a 2-hour infusion) plus standard medical therapy or standard medical therapy alone. The primary efficacy outcome is the proportion of patients achieving an excellent functional outcome (modified Rankin Scale score of 0-1) at 90 days. The primary safety outcome is the incidence of symptomatic intracranial hemorrhage within 48 hours after randomization. A total of 786 participants are planned to be enrolled to detect a 10% absolute difference in the primary outcome with 80% power.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Eptifibatide (Integrilin), Standard Medical Therapy
- Keywords
- Acute Ischemic Stroke, Intravenous thrombolysis, Eptifibatide, Neurological deterioration
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptifibatide (Integrilin)Drug
Participants will receive intravenous eptifibatide (135 μg/kg bolus, followed by 0.75 μg/kg/min infusion for 2 hours) initiated within 60 minutes after completion of standard intravenous thrombolysis (either alteplase or tenecteplase). Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis until the follow-up period of 90 days.
Standard Medical TherapyDrug
Participants will not receive intravenous eptifibatide after completion of standard intravenous thrombolysis. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis until the follow-up period of 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Eptifibatide (Integrilin) | Experimental | Participants randomized to this arm will receive intravenous eptifibatide (135 μg/kg bolus, followed by 0.75 μg/kg/min infusion for 2 hours) initiated within 60 minutes after completion of standard intravenous thrombolysis (either alteplase or tenecteplase). Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis until the follow-up period of 90 days. Receives: Drug: Eptifibatide (Integrilin) |
| Standard Medical Therapy | Active comparator | Participants randomized to this arm will not receive intravenous eptifibatide after completion of standard intravenous thrombolysis. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis until the follow-up period of 90 days. Receives: Drug: Standard Medical Therapy |
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
Conversion to Endovascular Therapy
Proportion of patients who converted to endovascular therapy
Measured: 24 hours post-randomization
Functionally independent
modified Rankin scale score of 0 to 2
Measured: 90 days post-randomization
Change in NIHSS Score at 48 (±12) Hours
Change in NIHSS score from pre-randomization to 48 (±12) hours
Measured: 48 (±12) hours post-randomization
Change in NIHSS Score at Discharge or Day 6 (±1)
Change in NIHSS score from pre-randomization to discharge or day 6 (±1)
Measured: Day 6 (±1) or discharge post-randomization, whichever came first
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 (±12) 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 major extracranial bleeding within 48 (±12) hours
GUSTO criteria: moderate and severe bleeding
Measured: 48 (±12) hours post-randomization
Incidence of non-hemorrhagic serious adverse events
Including but not limited to cerebral herniation, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis, and psychiatric symptoms
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 posted16 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 786 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Hainan Medical University, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
- Investigators
- Zhongming Qiu, MD, Principal investigator, Xinqiao Hospital of the Army Medical UniversityZhenqiang Zhao, MD, Principal investigator, The First Affiliated Hospital of Hainan Medical UniversityDaojun Hong, MD, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347626
- Sponsor's protocol ID
- E-TWIST
- Acronym
- E-TWIST
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.
PubMed 3201508Seners P, Ben Hassen W, Lapergue B, Arquizan C, Heldner MR, Henon H, Perrin C, Strambo D, Cottier JP, Sablot D, Girard Buttaz I, Tamazyan R, Preterre C, Agius P, Laksiri N, Mechtouff L, Bejot Y, Duong DL, Mounier-Vehier F, Mione G, Rosso C, Lucas L, Papassin J, Aignatoaie A, Triquenot A, Carrera E, Niclot P, Obadia A, Lyoubi A, Garnier P, Crainic N, Wolff V, Tracol C, Philippeau F, Lamy C, Soize S, Baron JC, Turc G; MINOR-STROKE Collaborators. Prediction of Early Neurological Deterioration in Individuals With Minor Stroke and Large Vessel Occlusion Intended for Intravenous Thrombolysis Alone. JAMA Neurol. 2021 Mar 1;78(3):321-328. doi: 10.1001/jamaneurol.2020.4557.
PubMed 33427887Han L, Hou Z, Ma M, Ding D, Wang D, Fang Q. Impact of glycosylated hemoglobin on early neurological deterioration in acute mild ischemic stroke patients treated with intravenous thrombolysis. Front Aging Neurosci. 2023 Jan 12;14:1073267. doi: 10.3389/fnagi.2022.1073267. eCollection 2022.
PubMed 36711206Yang T, Fan K, Cao Y, Yan J, Han Z. Stroke Type, Etiology, Clinical Features and Prognosis of Diabetic Patients in Southern China. Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620973090. doi: 10.1177/1076029620973090.
PubMed 33296224Tu WJ, Chao BH, Ma L, Yan F, Cao L, Qiu H, Ji XM, Wang LD. Case-fatality, disability and recurrence rates after first-ever stroke: A study from bigdata observatory platform for stroke of China. Brain Res Bull. 2021 Oct;175:130-135. doi: 10.1016/j.brainresbull.2021.07.020. Epub 2021 Jul 27.
PubMed 34329730Wang M, Wang CJ, Gu HQ, Meng X, Jiang Y, Yang X, Zhang J, Xiong YY, Zhao XQ, Liu LP, Wang YL, Wang YJ, Li ZX. Sex Differences in Short-Term and Long-Term Outcomes Among Patients With Acute Ischemic Stroke in China. Stroke. 2022 Jul;53(7):2268-2275. doi: 10.1161/STROKEAHA.121.037121. Epub 2022 Feb 8.
PubMed 35130717Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
PubMed 28052979The Lancet Public Health. Strengthening public health for a Healthy China. Lancet Public Health. 2021 Dec;6(12):e866. doi: 10.1016/S2468-2667(21)00261-9. No abstract available.
PubMed 34838189
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eptifibatide Therapy Following Intravenous Thrombolysis in Acute Ischemic Stroke Patients Within 4.5 to 24 Hours After Onset: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07347626
- Acronym / sponsor ID
- E-TWIST / E-TWIST
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Intravenous thrombolysis, Eptifibatide, Neurological deterioration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 786 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Hainan Medical University, The First Affiliated Hospital of Nanchang University
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 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.
This is a multicenter, randomized, open-label, blinded-endpoint clinical trial designed to evaluate the efficacy and safety of early administration of eptifibatide following intravenous thrombolysis in patients with acute ischemic stroke who present 4.5 to 24 hours after symptom onset.
Detailed description
Several clinical trials (e.g., TRACE-3, EXPECTS, HOPE) have successfully extended the time window for intravenous thrombolysis (IVT) from the conventional 4.5 hours up to 24 hours after symptom onset by utilizing advanced imaging selection techniques. Consequently, the 2024 Chinese guidelines for reperfusion therapy recommend IVT for patients presenting 4.5 to 24 hours after onset, based on imaging selection criteria. However, clinical practice indicates that a considerable proportion of patients exhibit suboptimal recanalization outcomes or even experience early neurological deterioration (END) despite receiving standard IVT. Previous research, such as the ASSET-IT trial, has primarily focused on patients treated within 4.5 hours of onset. For the growing population of "extended-window" (4.5-24 hours) patients receiving IVT facilitated by advances in imaging, the optimal antiplatelet strategy following thrombolysis remains an area with no high-level evidence. Therefore, this study aims to evaluate the efficacy and safety of early administration of eptifibatide following standard IVT (with tenecteplase or alteplase) in patients with acute ischemic stroke who present 4.5 to 24 hours after symptom onset. Patients who have received standard IVT but exhibit early neurological deterioration, fluctuation, or lack of significant improvement within 1 hour post-thrombolysis will be randomized 1:1 to receive either eptifibatide (a single intravenous bolus followed by a 2-hour infusion) plus standard medical therapy or standard medical therapy alone. The primary efficacy outcome is the proportion of patients achieving an excellent functional outcome (modified Rankin Scale score of 0-1) at 90 days. The primary safety outcome is the incidence of symptomatic intracranial hemorrhage within 48 hours after randomization. A total of 786 participants are planned to be enrolled to detect a 10% absolute difference in the primary outcome with 80% power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eptifibatide (Integrilin) | Experimental | Drug: Eptifibatide (Integrilin)Participants randomized to this arm will receive intravenous eptifibatide (135 μg/kg bolus, followed by 0.75 μg/kg/min infusion for 2 hours) initiated within 60 minutes after completion of standard intravenous thrombolysis (either alteplase or tenecteplase). Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis until the follow-up period of 90 days. |
| Standard Medical Therapy | Active comparator | Drug: Standard Medical TherapyParticipants randomized to this arm will not receive intravenous eptifibatide after completion of standard intravenous thrombolysis. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis 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 (9 listed)
- Age ≥ 18 years.
- Acute ischemic stroke, with the time interval from last known well to hospital presentation being 4.5 to 24 hours.
- NIHSS score ≥ 4 before randomization; if large or medium vessel occlusion is present, an NIHSS score ≤ 10 is also required.
- Presence of any of the following conditions after completion of standard intravenous thrombolysis:
- Ability to receive the assigned study drug within 60 minutes after intravenous thrombolysis.
Key exclusion criteria (17 listed)
- Intracranial hemorrhage confirmed by CT or MRI.
- Planned endovascular therapy.
- Presence of any definite cardioembolic source, including: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous echo contrast in the left atrium, or ejection fraction < 30%.
- Pre-stroke modified Rankin Scale (mRS) score ≥ 2.
- Renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 μmol/L [2.5 mg/dL]).
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 |
|---|---|---|
| Eptifibatide (Integrilin)Participants will receive intravenous eptifibatide (135 μg/kg bolus, followed by 0.75 μg/kg/min infusion for 2 hours) initiated within 60 minutes after completion of standard intravenous thrombolysis (either alteplase or tenecteplase). Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis until the follow-up period of 90 days. | Drug | Eptifibatide (Integrilin) |
| Standard Medical TherapyParticipants will not receive intravenous eptifibatide after completion of standard intravenous thrombolysis. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 24h after thrombolysis until the follow-up period of 90 days. | Drug | Standard Medical Therapy |
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
Conversion to Endovascular Therapy
Time frame: 24 hours post-randomization
Functionally independent
Time frame: 90 days post-randomization
Change in NIHSS Score at 48 (±12) Hours
Time frame: 48 (±12) hours post-randomization
Change in NIHSS Score at Discharge or Day 6 (±1)
Time frame: Day 6 (±1) or discharge post-randomization, whichever came first
Health-related quality of life
Time frame: 90 days post-randomization
Symptomatic intracranial hemorrhage
Time frame: 48 (±12) hours post-randomization
Mortality
Time frame: 90 days post-randomization
Incidence of major extracranial bleeding within 48 (±12) hours
Time frame: 48 (±12) hours post-randomization
Incidence of non-hemorrhagic 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 16 Jan 2026.
- Results publication: PubMed 3201508Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.
- Results publication: PubMed 33427887Seners P, Ben Hassen W, Lapergue B, Arquizan C, Heldner MR, Henon H, Perrin C, Strambo D, Cottier JP, Sablot D, Girard Buttaz I, Tamazyan R, Preterre C, Agius P, Laksiri N, Mechtouff L, Bejot Y, Duong DL, Mounier-Vehier F, Mione G, Rosso C, Lucas L, Papassin J, Aignatoaie A, Triquenot A, Carrera E, Niclot P, Obadia A, Lyoubi A, Garnier P, Crainic N, Wolff V, Tracol C, Philippeau F, Lamy C, Soize S, Baron JC, Turc G; MINOR-STROKE Collaborators. Prediction of Early Neurological Deterioration in Individuals With Minor Stroke and Large Vessel Occlusion Intended for Intravenous Thrombolysis Alone. JAMA Neurol. 2021 Mar 1;78(3):321-328. doi: 10.1001/jamaneurol.2020.4557.
- Results publication: PubMed 36711206Han L, Hou Z, Ma M, Ding D, Wang D, Fang Q. Impact of glycosylated hemoglobin on early neurological deterioration in acute mild ischemic stroke patients treated with intravenous thrombolysis. Front Aging Neurosci. 2023 Jan 12;14:1073267. doi: 10.3389/fnagi.2022.1073267. eCollection 2022.
- Results publication: PubMed 33296224Yang T, Fan K, Cao Y, Yan J, Han Z. Stroke Type, Etiology, Clinical Features and Prognosis of Diabetic Patients in Southern China. Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620973090. doi: 10.1177/1076029620973090.
- Results publication: PubMed 34329730Tu WJ, Chao BH, Ma L, Yan F, Cao L, Qiu H, Ji XM, Wang LD. Case-fatality, disability and recurrence rates after first-ever stroke: A study from bigdata observatory platform for stroke of China. Brain Res Bull. 2021 Oct;175:130-135. doi: 10.1016/j.brainresbull.2021.07.020. Epub 2021 Jul 27.
- Results publication: PubMed 35130717Wang M, Wang CJ, Gu HQ, Meng X, Jiang Y, Yang X, Zhang J, Xiong YY, Zhao XQ, Liu LP, Wang YL, Wang YJ, Li ZX. Sex Differences in Short-Term and Long-Term Outcomes Among Patients With Acute Ischemic Stroke in China. Stroke. 2022 Jul;53(7):2268-2275. doi: 10.1161/STROKEAHA.121.037121. Epub 2022 Feb 8.
- Results publication: PubMed 28052979Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
- Results publication: PubMed 34838189The Lancet Public Health. Strengthening public health for a Healthy China. Lancet Public Health. 2021 Dec;6(12):e866. doi: 10.1016/S2468-2667(21)00261-9. No abstract available.
- Individual participant dataSharing planned: Undecided
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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
Xinqiao Hospital of the Army Medical University
Zhenqiang Zhao, MD principal investigator
The First Affiliated Hospital of Hainan Medical University
Daojun Hong, MD principal investigator
The First Affiliated Hospital of Nanchang University
6 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 Eptifibatide (Integrilin) and Standard Medical Therapy in people with Acute Ischemic Stroke, run by Xinqiao Hospital of Chongqing at 6 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 9 inclusion and 17 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 16 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 6 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. 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 Wei Li, MD (+86 18976574937, weiligysy@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 NCT07347626, which also lists 8 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 16 Jan 2026; AzTrials last refreshed its copy on 5 Nov 2026.