Eptifibatide for Extended Window Ischemic Stroke After Thrombolysis
ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorXinqiao Hospital of Chongqing
About this 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.
Eligibility criteria
Qualifiers
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.
No significant neurological improvement within 1 hour (defined as a change in NIHSS score ≤ 1 point from baseline).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Eptifibatide (Integrilin)
- Standard Medical Therapy
Treatment groups
786 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xinqiao Hospital of Chongqing
Lead sponsor
The First Affiliated Hospital of Hainan Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Source ClinicalTrials.gov