Status:
NOT_YET_RECRUITING
The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile
Lead Sponsor:
Sun U. Kwon
Conditions:
Stroke, Acute Ischemic
PCSK9 Inhibitor
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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 investiga...
Detailed Description
This clinical trial will be recommended to patients aged 19 and older who are admitted with ischemic stroke accompanied by atherosclerosis of large arteries, rather than cardiac embolism. Upon confirm...
Eligibility Criteria
Inclusion
- 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.
- National Institutes of Health Stroke Scale(NIHSS) score of 15 or less at admission
- Patients with the capacity to consent for participation in the clinical trial.
Exclusion
- 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
- Pre-stroke mRS score of 3 or higher
- Severe liver failure (liver enzyme \> 3 times the upper normal limit) or renal failure (serum Creatinine \> 2mg/dL or estimated glomerular filtration rate \< 30 mL/min/1.73m2)
- Anemia (hemoglobin \< 8mg/dL) or thrombocytopenia (platelet count \< 100K)
- Uncontrolled diabetes not managed by medication or insulin
- Pregnant or breastfeeding patients
- Patients already receiving PCSK-9 inhibitors
- Patients deemed inappropriate for participation in the clinical trial by the investigator for other reasons.
Key Trial Info
Start Date :
October 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06083961
Start Date
October 15 2023
End Date
November 15 2026
Last Update
October 16 2023
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736