Hybutimibe 10mg QD
DrugHybutimibe was added to the conventional treatment
NCT Number: NCT06641661
Significant individual differences may lead to differences in patients' responses to drug therapy and lead to an increased incidence of adverse reactions. However, there are currently very limited data on the genetic variation of the NPC1L1 gene in the Chinese population. In view of the important role of NPC1L1 gene polymorphism in cholesterol absorption, lipid profile, coronary heart disease prevalence and ezetimibe response, it is necessary to focus on the allele frequency analysis of NPC1L1 gene polymorphism in the Chinese population, and to further explore the therapeutic response of NPC1L1 gene polymorphism and Hybutimibe.
With reference to previous domestic and foreign literature reports and HapMap project (http://hapmap.ncbi.nlm. nih.gov/)SNP) distribution, this study selected NPC1L1 gene loci with relatively in-depth clinical research. rs2072183, rs4720470, rs2073547 were analyzed. The minimum allele frequency (MAF) of the above loci were all greater than 10%, and it has been confirmed that genetic variation exists between different diseases and different races, which may affect the lipid profile , the risk of coronary heart disease and the response to hybomaib treatment. However, the variability of rs2072183 in response to Hybutimibe needs to be further verified, and the effects of rs4720470 and rs2073547 gene polymorphisms on drug response also need to be targeted. In order to further determine the correlation between the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe, we conducted this study to observe the distribution frequency of NPC1L1 gene polymorphisms at rs2072183, rs4720470 and rs2073547 in high-risk/extremely high-risk ASCVD patients. To explore the correlation between NPC1L1 gene polymorphisms and the efficacy and safety of Hybutimibe combined with moderate-intensity statins in the treatment of high-risk/very high-risk ASCVD patients. This is the first time to explore the distribution of NPC1L1 polymorphism in high/very high risk ASCVD population in China, which will provide genetic evidence for the correct use of Hybutimibe and moderate intensity statin therapy, and provide further evidence-based medical evidence for the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hybutimibe was added to the conventional treatment
Time frame: at week 12 of treatment
Rate of LDL-C change from baseline in high-risk/very high-risk ASCVD patients at week 12 of treatment
Time frame: At the 4th week of treatment
At the 4th week of treatment, LDL-C change rate from baseline in high-risk/very high-risk ASCVD patients
Time frame: at the 4th and 12th week of treatment
Changes in HDL-C, TC and TG levels at the 4th and 12th week of treatment.
Time frame: at the 4th and 12th week of treatment
Changes in levels of alanine aminotransferase, aspartate aminotransferase and creatine kinase at the 4th and 12th week of treatment.
Time frame: at enrollment
Polymorphism and distribution frequency of NPC1L1 gene rs2072183, rs4720470 and rs2073547 in high-risk/extremely high-risk ASCVD patients.
Contact information is provided by the study sponsor or research team.
Qianfoshan Hospital
Other
The Association Between NPC1L1 Gene Polymorphism and the Efficacy and Safety of Hybutimibe in High/very High Risk ASCVD Patients
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