Tilføjelse af Evolocumab til konventionel lipid-sænkende terapi for hypertriglyceridemi-induceret akut pankreatitis
Tilføjelse af Evolocumab til konventionel lipid-sænkende terapi for hypertriglyceridæmi-induceret akut pankreatitis: Et pilotforsøg med randomiseret kontrol
The severity of hypertriglyceridemia induced acute pancreatitis (HTG-AP) is closely related to the serum triglyceride (TG) levels. The higher the TG levels, the greater the risk of developing severe acute pancreatitis (SAP). Previous expert consensus has pointed out that the key to treating HTG-AP is to rapidly lower serum TG levels to below 5.65 mmol/L. Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, which is often used to treat familial hypercholesterolemia, mixed dyslipidemia and atherosclerotic cardiovascular disease. At the same time, evolocumab also has the effect of reducing TG and may provide a feasible option for the management of HTG-AP. However, its efficacy and safety in reducing TG in patients with HTG-AP remain controversial. This study is a multicenter randomized controlled trial to evaluate the efficacy and safety of adding evolocumab to conventional lipid-lowering therapy in patients with HTG-AP.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Overall, 60 patients with HTG-AP will be included. These patients will be randomly assigned in a 1:1 ratio to the conventional lipid-lowering therapy group and the conventional lipid-lowering therapy + evolocumab group. The primary endpoints are the TG levels at days 3 and 7 after treatment, and the rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L at the same time points. Secondary endpoints include blood levels of total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and lipoprotein(a) at days 3 and 7; the incidence of recurrent acute pancreatitis (RAP), SAP, and other complications; as well as the length of hospital stay and total hospitalization costs.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Xingshun Qi
- Telefonnummer: 18909881019
- E-mail: xingshunqi@126.com
Undersøgelse Kontakt Backup
- Navn: Yifan Guo
- Telefonnummer: 18341833373
- E-mail: guoyifan202402@163.com
Studiesteder
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110840
- Rekruttering
- Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
-
Kontakt:
- Xingshun Qi
- Telefonnummer: 18909881019
- E-mail: xingshunqi@126.com
-
Kontakt:
- Yifan Guo
- Telefonnummer: 18341833373
- E-mail: guoyifan202402@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 18~75 years
- Patients with HTG-AP
- Mixed hyperlipidemia
- Sign the informed consent form
Exclusion Criteria:
- Patients who have received lipid-lowering drugs or blood purification treatment within one week before enrollment
- Patients who have used evolocumab within one month before enrollment
- Patients who are accompanied by diseases that can seriously affect the survival
- Patients who have participated in the clinical research of other drugs within one month
- Patients who are pregnant or breastfeeding
- Patients with allergic asthma, allergic urticaria, eczema, and those who have a clear history of multiple drug and food allergies
- Other circumstances that researchers consider not suitable for participation in this study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Konventionel lipid-sænkende terapi + Evolocumab-gruppe
|
The clinicians strictly follow the treatment strategy for HTG-AP as stipulated in the 2021 "Emergency Expert Consensus on Diagnosis and Treatment of Hypertriglyceridemia Induced Acute Pancreatitis" to provide conventional lipid-lowering treatment for the patients, including dietary adjustments, fibrates, low-molecular-weight heparin, and insulin, etc. On the basis of conventional lipid-lowering treatment, 140mg of evolocumab is added by slow subcutaneous injection every two weeks, and the patients' responses are observed during this period.
Andre navne:
|
|
Aktiv komparator: Konventionel lipid-sænkende behandlingsgruppe
|
This group only receives conventional lipid-lowering treatment without adding evolocumab.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
TG-niveauerne på den 3. og 7. dag efter behandling
Tidsramme: 3 dage og 7 dage
|
3 dage og 7 dage
|
|
Raterne for opnåelse af TG-niveauer under 5,65 mmol/L og 1,7 mmol/L på den 3. og 7. dag efter behandling
Tidsramme: 3 dage og 7 dage
|
3 dage og 7 dage
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serumniveauerne for TC, HDL, LDL og lipoprotein(a) på 3. og 7. dag efter behandling
Tidsramme: 3 dage og 7 dage
|
3 dage og 7 dage
|
|
Forekomsten af RAP, SAP og andre komplikationer
Tidsramme: 6 måneder
|
6 måneder
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Blom DJ, Hala T, Bolognese M, Lillestol MJ, Toth PD, Burgess L, Ceska R, Roth E, Koren MJ, Ballantyne CM, Monsalvo ML, Tsirtsonis K, Kim JB, Scott R, Wasserman SM, Stein EA; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014 May 8;370(19):1809-19. doi: 10.1056/NEJMoa1316222. Epub 2014 Mar 29.
- Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Wu BU, Johannes RS, Sun X, Tabak Y, Conwell DL, Banks PA. The early prediction of mortality in acute pancreatitis: a large population-based study. Gut. 2008 Dec;57(12):1698-703. doi: 10.1136/gut.2008.152702. Epub 2008 Jun 2.
- Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, Langslet G, Scott R, Olsson AG, Sullivan D, Hovingh GK, Cariou B, Gouni-Berthold I, Somaratne R, Bridges I, Scott R, Wasserman SM, Gaudet D; RUTHERFORD-2 Investigators. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):331-40. doi: 10.1016/S0140-6736(14)61399-4. Epub 2014 Oct 1.
- Zengwu Wang, Jing Liu, Jianjun Li, et al. Chinese Guidelines for Lipid Management (2023). Chinese Journal of Circulation. 2023; 38 (03) : 237-271.
- Ong Y, Shelat VG. Ranson score to stratify severity in Acute Pancreatitis remains valid - Old is gold. Expert Rev Gastroenterol Hepatol. 2021 Aug;15(8):865-877. doi: 10.1080/17474124.2021.1924058. Epub 2021 May 13.
- Qi R, Liu H, Li X, Chen M. Successful use of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Hypertriglyceridemia-induced Acute Pancreatitis: A Case Report. Curr Cardiol Rev. 2025;21(3):e1573403X343784. doi: 10.2174/011573403X343784241115055037.
- Chen H, Li X, Chen J, Zhao Y, Zhang W, Li H, Qi X. Lipid-lowering effect of evolocumab in hypertriglyceridemia-induced acute pancreatitis. Eur J Pharmacol. 2025 Nov 5;1006:178148. doi: 10.1016/j.ejphar.2025.178148. Epub 2025 Sep 16.
- Lu W, Wang L, Du C, Qin L, Li J, Wang H. PCSK9 Inhibitors in Multi-Branch Lesions in Coronary Artery Disease with Substandard Lipid-Lowering Effects. Altern Ther Health Med. 2024 Aug;30(8):356-360.
- Tan H, Li W, Huang Z, Han Y, Huang X, Li D, Xing X, Monsalvo ML, Wu Y, Mao J, Xin L, Chen J; HUA TUO study investigators. Efficacy and Safety of Evolocumab in Chinese Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia: 12-Week Primary Results of the HUA TUO Randomized Clinical Trial. Cardiol Ther. 2023 Jun;12(2):341-359. doi: 10.1007/s40119-023-00304-x. Epub 2023 Feb 21.
- Wiggins BS, Senfield J, Kassahun H, Lira A, Somaratne R. Evolocumab: Considerations for the Management of Hyperlipidemia. Curr Atheroscler Rep. 2018 Mar 6;20(4):17. doi: 10.1007/s11883-018-0720-3.
- Lu Z, Zhang G, Guo F, Li M, Ding Y, Zheng H, Wang D. Elevated triglycerides on admission positively correlate with the severity of hypertriglyceridaemic pancreatitis. Int J Clin Pract. 2020 Mar;74(3):e13458. doi: 10.1111/ijcp.13458. Epub 2019 Dec 14.
- Xin Hong, Liming Wang, Zhengliang Zhang, et al. Emergency Expert Consensus on Diagnosis and Treatment of Hypertriglyceridemia Induced Acute Pancreatitis [J]. Chinese General Practice, 2021, 24(30): 3781-93
- Na Zhang, Haiyan Zhang, Xiaohong Guo, et al. Meta-analysis of etiological changes of acute pancreatitis in China in the past Decade [J]. Chinese Journal of Gastroenterology and Imaging (Electronic Edition), 2016, 6(02): 71-5
- Pancreatic Surgery Group, Surgical Branch of the Chinese Medical Association Chinese Guidelines for Diagnosis and Treatment of Acute Pancreatitis (2021) [J]. Chinese Journal of Digestive Surgery, 2021, 20(07): 730-9.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Peptidhormoner
- Peptider
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Ethers
- Kulbrinter
- Kulbrinter, cyklisk
- Kulhydrater
- Syrer, acyklisk
- Carboxylsyrer
- Kulbrinter, aromatisk
- Fenoler
- Benzenderivater
- Heparin
- Glycosaminoglycans
- Polysaccharider
- Butyrater
- Insuliner
- Pancreashormoner
- Phenylethere
- Isobutyrater
- Proinsulin
- Insulin
- Heparin, lavmolekylær vægt
- Evolocumab
- Fibersyre
Andre undersøgelses-id-numre
- XHNKKY-HTGAP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .