Health TrialsbyHealthPanel

Safely Quenching Complement in Stroke Survivors

ConditionsAcute Ischemic StrokeCerebral Infarction
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorColumbia University

About this trial

This study will include adults (ages 18-80) who have had a stroke caused by a large blood clot blocking blood flow in the brain. All patients in the study must have already had a treatment called a thrombectomy, where doctors remove the clot to help blood flow return to the brain.

The goal of this study is to test the safety of a drug called EMPAVELI (pegcetacoplan). This drug is meant to lower swelling and inflammation that can happen after blood flow returns. The hope is that it may help protect the brain from more damage and improve recovery.

People in the study will get three doses of EMPAVELI through an EMPAVELI-designed pump 0-3 hours post thrombectomy surgery and 24 and 48 hours after the initial dose. Doctors will check them with exams, blood tests, brain scans, and other tests while they are there. Patients will also have follow-up visits at 30 and 90 days to see how they are doing, per the usual standard of care.

This research is important because, even with current stroke treatments, many patients still have problems like disability. If this drug is found to be safe, it could lead to better treatments to protect the brain and help people recover more fully after a stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (18-80 years old)

Diagnosis of AIS due to anterior circulation (Intracranial ICA, M1 MCA) LVO with evidence of complete/near-complete revascularization following EVT (mTICI ≥2b).

Enrollment within 24 hours of reperfusion, with reperfusion occurring within 24 hours of ictus onset.

Body weight ≥ 50 kg.

Disqualifiers

Pregnant or lactating female

Suspected pregnancy.

Renal insufficiency (GFR<30mL/minute OR creatinine >2 mg/dL OR need for renal replacement therapy (RRT) at time of admission).

Platelet count < 50,000/mm³

Trial design

Design model

Single group

Treatments tested in this trial

  • Pegcetacoplan Injection [Empaveli]

    Drug

    In this study, participants will receive three 1,080 mg doses delivered within 0-3 hours following endovascular thrombectomy, and at 24 and 48 hours after the initial dose. Pegcetacoplan is FDA-approved for the treatment of paroxysmal nocturnal hemoglobinuria and is being evaluated in this study for its safety and tolerability in acute ischemic stroke patients following reperfusion.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Empaveli (Pegcetacoplan) TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

To evaluate the safety and tolerability of pegcetacoplan (Empaveli) in adult patients with acute ischemic stroke following endovascular thrombectomy, as measured by the incidence, type, and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs).

Time frame
Through 90 days post-treatment

Secondary outcomes

1

Neurological Functional Outcome

Functional outcome as measured by the modified Rankin Scale (mRS). The scale is from 0-6, where 0 indicates no symptoms at all and 6 indicates Death. Therefore, higher scores represent worse outcomes.

Time frame
Through 90 days post-treatment
2

Neurological Deficit Severity

Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline. The scale is graded from 0-42, with a score of 0 indicating no stroke while a maximum score of 42 indicates severe stroke. A higher score represents greater stroke severity.

Time frame
Baseline through 90 days
3

Biomarker Response

Changes in complement and neuroinjury biomarkers (e.g., C3, C3b, S100b, GFAP)

Time frame
Baseline through 90 days
4

Maximum Plasma Concentration [Cmax] of Pegcetacoplan

Maximum observed plasma concentration (Cmax) of pegcetacoplan following administration.

Time frame
Through 72 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Columbia University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: