Eptifibatide for Extended Window Ischemic Stroke After Thrombolysis

NCT07347626 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: E-TWIST
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Intravenous thrombolysis; Eptifibatide; Neurological deterioration

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days post-randomization

Secondary Outcomes (10)

• Ordinal degree of disability

  90 days post-randomization

• Conversion to Endovascular Therapy

  24 hours post-randomization

• Functionally independent

  90 days post-randomization

• Change in NIHSS Score at 48 (±12) Hours

  48 (±12) hours post-randomization

• Change in NIHSS Score at Discharge or Day 6 (±1)

  Day 6 (±1) or discharge post-randomization, whichever came first

Study Arms (2)

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.

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.

Drug: Standard Medical Therapy

Interventions

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.

Eptifibatide (Integrilin)

Standard Medical Therapy DRUG

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.

Standard Medical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• The First Affiliated Hospital of Nanchang University: collaborator
• The First Affiliated Hospital of Hainan Medical College: collaborator

Study Sites (6)

Xinqiao Hospital and The Second Affiliated Hospital

Chongqing, Chongqing Municipality, 400000, China

Location

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570100, China

Location

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

Location

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China

Location

The Affiliated Hospital of Jinggangshan University

Ji’an, Jiangxi, 343000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (8)

• 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.

  PMID: 3201508 RESULT

• Seners 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.

  PMID: 33427887 RESULT

• Han 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.

  PMID: 36711206 RESULT

• Yang 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.

  PMID: 33296224 RESULT

• Tu 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.

  PMID: 34329730 RESULT

• Wang 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.

  PMID: 35130717 RESULT

• Wang 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.

  PMID: 28052979 RESULT

• The 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.

  PMID: 34838189 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Zhongming Qiu, MD

  Xinqiao Hospital of the Army Medical University

  PRINCIPAL INVESTIGATOR

• Zhenqiang Zhao, MD

  The First Affiliated Hospital of Hainan Medical University

  PRINCIPAL INVESTIGATOR

• Daojun Hong, MD

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Li, MD

CONTACT

+86 18976574937; weiligysy@163.com

Jing Lin, MD

CONTACT

+86 15626456674; linjingsys2016@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (6)