NCT06083961Not yet recruitingPhase 4
The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 12 Sept 2023
- Start date
- 15 Oct 2023
- Primary completion date
- 15 Oct 2026
- Lead sponsor
- Sun U. Kwon
- Diseases
- Stroke
- NCT number
- NCT06083961
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 15 Oct 2023 to the primary completion date, 15 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients unable to take statins or PCSK9 inhibitors
- Patients already receiving PCSK-9 inhibitors
Other illness
- 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
Lab values
- 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)
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.