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The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile

ConditionsStroke, Acute IschemicPCSK9 Inhibitor
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSun U. Kwon

About this trial

The goal of this clinical trial is to test the effect of proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors) in acute ischemic stroke patients associated with atherosclerosis by investigating

1. the change in lipid profile compared to baseline results 2. the effects on prognosis of stroke The participants will be given PCSK9 inhibitor right after confirmation of acute ischemic stroke, and the investigators will compare the results to the control group, whom are acute ischemic stroke patients treated with conventional lipid lowering therapy, statin and/or ezetimibe.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-cardioembolic Stroke

Acute Ischemic stroke within 7 days of symptom onset (confirmed by CT or MRI)

Age 19 and above

Significant stenosis associated with atherosclerosis in major intracranial / extracranial vessels.

Disqualifiers

Presence of high-risk factors for cardioembolism

Risk of ischemic stroke due to thrombosis from other causes

Patients with hemorrhagic stroke, brain tumors, or brain abscesses

Patients unable to take statins or PCSK9 inhibitors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alirocumab

    Drug

    Initial alirocumab, single dose of 300mg, subcutaneous injection

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AlirocumabExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

LDL change rate

The change rate of LDL in PCSK9 inhibitor treated group (alirocumab group) compared to standard of care group.

Time frame
LDL level at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
2

Achievement rate to target LDL level

The investigators intend to use 3 different criteria - 1. LDL under 70mg/dl 2. LDL under 55mg/dL 3. LDL decrement over 50% compared to baseline (day0 LDL)

Time frame
LDL target achievement rate at day-1 of hospitalization, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).

Secondary outcomes

1

Change of total cholesterol(TC)

The change of TC during admission and at Outpatient department(OPD) follow up

Time frame
TC levels are checked all together with LDL level, which is at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
2

Change triglyceridTG)

The change of TG during admission and at Outpatient department(OPD) follow up

Time frame
TG levels are checked all together with LDL level, which is at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
3

Change of High density lipoprotein(HDL)

The change of HDL during admission and at Outpatient department(OPD) follow up

Time frame
HDL levels are checked all together with LDL level, which is at initial state (before injection, day-0), day-1, day-3, before discharge (normally day-5 to day-7), and day-30 (Outpatient department follow up).
4

Change of Apolipoprotein-B

The change of Apolipoprotein-B during admission and at Outpatient department(OPD) follow up

Time frame
Apolipoprotein-B is collected at day-1, once.

Other outcomes

Sponsors and contacts

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

Sun U. Kwon

Lead sponsor

Asan Medical Center

Sponsor institution

Source ClinicalTrials.gov

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