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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

786 Participants
are divided into 2 treatment groups
Group A: Eptifibatide (Integrilin)Experimental treatment 1 intervention
Group B: Standard Medical TherapyActive comparator 1 intervention

Trial outcomes

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.

Time frame
90 days post-randomization

Secondary outcomes

1

Ordinal degree of disability

Ordinal degree of disability on the modified Rankin scale score at 90 days (shift analysis)

Time frame
90 days post-randomization
2

Conversion to Endovascular Therapy

Proportion of patients who converted to endovascular therapy

Time frame
24 hours post-randomization
3

Functionally independent

modified Rankin scale score of 0 to 2

Time frame
90 days post-randomization
4

Change in NIHSS Score at 48 (±12) Hours

Change in NIHSS score from pre-randomization to 48 (±12) hours

Time frame
48 (±12) hours post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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