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Clinical Trials in China / NCT07347626
Starting soon Phase 3

Eptifibatide for Extended Window Ischemic Stroke After Thrombolysis

NCT07347626 · tracked via the Priya Life Science China tracker
Sponsor
Xinqiao Hospital of Chongqing
Phase
Phase 3
Started
2026-03-01
Last updated
2026-01-16

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Eptifibatide (Integrilin)Standard Medical Therapy

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.

Standard Medical Therapy: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years. 2. Acute ischemic stroke, with the time interval from last known well to hospital presentation being 4.5 to 24 hours. 3. NIHSS score ≥ 4 before randomization; if large or medium vessel occlusion is present, an NIHSS score ≤ 10 is also required. 4. Presence of any of the following conditions after completion of standard intravenous thrombolysis: 1. No significant neurological improvement within 1 hour (defined as a change in NIHSS score ≤ 1 point from baseline). 2. Early neurological deterioration within 1 hour of onset (defined as an increase in NIHSS score ≥ 2 points from baseline). 3. Neurological fluctuation within 24 hours after symptom onset (defined as an increase in NIHSS score ≥ 2 points from the lowest value post-thrombolysis). 5. Ability to receive the assigned study drug within 60 minutes after intravenous thrombolysis. 6. Signed written informed consent obtained from the patient or their legal representative. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT or MRI. 2. Planned endovascular therapy. 3. 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%. 4. Pre-stroke modified Rankin Scale (mRS) score ≥ 2. 5. Renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 μmol/L \[2.5 mg/dL\]). 6. Known hypercoagulable state. 7. Platelet count \< 100 × 10⁹/L. 8. Pregnancy or lactation. 9. Allergy to eptifibatide, other glycoprotein IIb/IIIa inhibitors, aspirin, or clopidogrel. 10. History of non-atherosclerotic arteriopathy, including moyamoya disease, arterial dissection, or fibromuscular dysplasia. 11. Pre-existing neurological or psychiatric disease that would preclude accurate neurological assessment. 12. History of bleeding diathesis, severe cardiac disease, liver disease, or sepsis. 13. Brain tumor with mass effect on imaging (except for small meningiomas). 14. Evidence of intracranial arteriovenous malformation or aneurysm with diameter \> 5 mm on CT or MR angiography. 15. Current participation in another clinical trial. 16. Any terminal illness with life expectancy \< 6 months. 17. Anticipated inability to complete follow-up.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Xinqiao Hospital and The Second Affiliated Hospital Chongqing Chongqing Municipality
The First Affiliated Hospital of Hainan Medical University Haikou Hainan
Ganzhou People's Hospital Ganzhou Jiangxi
The First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi
The Affiliated Hospital of Jinggangshan University Ji’an Jiangxi
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi

More Xinqiao Hospital of Chongqing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347626 on ClinicalTrials.gov ↗ ← All trials in China