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)
Excellent functional outcome — 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.
Trial sites (6)
Facility
City
Region
Status
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
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.
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