Eptifibatide for Extended Window Ischemic Stroke After Thrombolysis

Prior treatment

• Planned endovascular therapy.

Other illness

• Intracranial hemorrhage confirmed by CT or MRI.
• Pre-stroke modified Rankin Scale (mRS) score ≥ 2.
• 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.
• Any terminal illness with life expectancy \< 6 months.

Lab values

• 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%.
• Renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 μmol/L \[2.5 mg/dL\]).
• Platelet count \< 100 × 10⁹/L.

Other

• Known hypercoagulable state.
• Pregnancy or lactation.
• 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.
• Anticipated inability to complete follow-up.

• 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.