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Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment increased: 40 → 60 participants Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Interventions: Conventional lipid-lowering therapy (Drug), Evolocumab 140 MG/ML [Repatha] (Drug) to Conventional lipid-lowering therapy (Drug), Evolocumab 140 MG/ML [Repatha] (Drug)
    • Eligibility criteria expanded, about 16 words
    • Study description revised
    • Publications: details revised at 10 of 15 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07388420
Lead Sponsor General Hospital of Shenyang Military Region
Conditions
(from sponsor)		 Hypertriglyceridemia Induced Acute Pancreatitis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov