UMIN ID: UMIN000053986
Registered date:27/03/2024
Efficacy of Inclisiran for Dyslipidemia
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | yslipidemia(Receiving evolocumab or taking maximum tolerated dose of statins) |
| Date of first enrollment | 2024/02/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Inclisiran administered to patients with treatment-resistant dyslipidemia (initial, 3 months, 9 months, and 15 months after initial administration) |
Outcome(s)
| Primary Outcome | LDL |
|---|---|
| Secondary Outcome | 1) HDL, T-cho, TG, RLP-cho, Lp(a) 2) BUN, Cr, eGFR, cystatin C 3) AST, ALT 4) Fatty acid 5) FMD, ABI 6) cardiovascular event, death 7) side effect |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Doctor's decision not to register to this regimen |
Related Information
| Primary Sponsor | Sekino Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Self funding |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akira Sezai |
| Address | 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan Japan 1738610 |
| Telephone | 03-3982-8111 |
| asezai.med@gmail.com | |
| Affiliation | Nihon University School of Medicine Department of Cardiovascular Surgery |
| scientific contact | |
| Name | Akira Sezai |
| Address | 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan Japan |
| Telephone | 03-3982-8111 |
| asezai.med@gmail.com | |
| Affiliation | Nihon University School of medicine Department of Cardiovascular Surgery |