Tests alirocumab early after acute ischemic stroke linked to atherosclerosis
Tests alirocumab, a cholesterol-lowering drug, in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 4
Where in South Korea
- Asan Medical CenterSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun U. Kwon
- Trial code
- NCT06083961
- Record updated
- 16 October 2023
- Original description
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 investigatingRead full original descriptionShow less
The Effect of Early Administration of PCSK9 Inhibitor, Alirocumab to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile, a Single Center Study, Registry Based, Pragmatic, Prospective 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.
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: Patients unable to take statins or PCSK9 inhibitors; Patients already receiving PCSK-9 inhibitors; Risk of ischemic stroke due to thrombosis from other causes; Patients with hemorrhagic stroke, brain tumors, or brain abscesses; Pre-stroke mRS score of 3 or higher; Uncontrolled diabetes not managed by medication or insulin; 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); Presence of high-risk factors for cardioembolism; Pregnant or breastfeeding patients; Patients deemed inappropriate for participation in the clinical trial by the investigator for other reasons.