Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
Study NCT ID:
NCT06784557
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-12-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ezetimibe on Gut Microbiota
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Gut Microbiota Alteration With Atorvastatin/Ezetimibe Combination in Patients With Atherosclerotic Cardiovascular Disease
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ezetimibe exerts its primary effects by inhibiting intestinal cholesterol absorption through the NPC1L1 protein. Beyond this, its impact on gut microbiota remains an area of interest. Gut microbiota has been implicated in cholesterol metabolism and CVD pathogenesis through metabolic and non-metabolic pathways. Modulating gut microbiota has been explored as a potential strategy to prevent CVDs.
Despite its intestinal mechanism, the influence of ezetimibe on gut microbiota composition has not been thoroughly investigated. Future studies are needed to elucidate its potential interactions with gut microbial communities and their implications for cholesterol metabolism and cardiovascular health.
Despite its intestinal mechanism, the influence of ezetimibe on gut microbiota composition has not been thoroughly investigated. Future studies are needed to elucidate its potential interactions with gut microbial communities and their implications for cholesterol metabolism and cardiovascular health.
Detailed Description:
1. Study Period The clinical trial spans 12 weeks to analyze baseline data and changes after treatment.
The study starts upon IRB approval, with participant recruitment concluding within 24 months and the entire study wrapping up within 48 months.
2. Study Design This is an investigator-initiated, prospective, single-center, open-label, randomized clinical trial.
It involves 110 coronary artery disease (CAD) patients in need of lipid-lowering therapy, divided into two groups:
Experimental Group (n=55): Moderate-intensity statin (Atorvastatin 20 mg) combined with Ezetimibe 10 mg.
Control Group (n=55): High-intensity statin monotherapy (Atorvastatin 40 mg). Primary Outcome: Changes in gut microbiota composition. Secondary Outcomes: Changes in blood lipid levels and inflammatory biomarkers.
3. Methods 3.1. Screening and Enrollment Participants are screened for eligibility based on inclusion and exclusion criteria.
After providing informed consent, participants are randomized into two groups (1:1 ratio) using a permuted block randomization method.
For those on prior statin or Ezetimibe therapy, a 2-week washout period is required before enrollment.
3.2. Study Medication
Participants receive their assigned treatment for 12 weeks, with medications administered orally once daily at consistent times, irrespective of meals:
High-Intensity Statin Group: Atorvastatin 40 mg. Combination Therapy Group: Atorvastatin 20 mg + Ezetimibe 10 mg. 3.3. Follow-Up Baseline data, including demographic details, blood tests, and stool samples, are collected at enrollment.
After 12 weeks of treatment, follow-up includes clinical evaluations, blood tests, and stool sample collection for post-treatment analysis.
4. Efficacy Evaluation 4.1. Primary Endpoint
Gut Microbiota Analysis:
Stool samples are analyzed using 16S rRNA sequencing.
Statistical tests compare microbiota differences:
Between groups at baseline (T-test or Mann-Whitney test). Pre- and post-treatment within groups (Paired t-test or Wilcoxon test). Intergroup changes over time (ANOVA test). 4.2. Secondary Endpoint Similar statistical methods are applied to assess changes in blood lipid levels and inflammatory biomarkers.
4.3. Subgroup Analysis
Specific subgroups undergo additional analysis:
Subgroup 1: Low-risk CAD patients (10-year ASCVD risk \<7.5%). Subgroup 2: Patients with poor response to therapy (LDL \>70 mg/dL after 12 weeks).
Subgroup 3: Recurrent CAD patients despite optimal therapy. Subgroup stool samples are analyzed using shotgun metagenomic sequencing for detailed microbial insights.
The study starts upon IRB approval, with participant recruitment concluding within 24 months and the entire study wrapping up within 48 months.
2. Study Design This is an investigator-initiated, prospective, single-center, open-label, randomized clinical trial.
It involves 110 coronary artery disease (CAD) patients in need of lipid-lowering therapy, divided into two groups:
Experimental Group (n=55): Moderate-intensity statin (Atorvastatin 20 mg) combined with Ezetimibe 10 mg.
Control Group (n=55): High-intensity statin monotherapy (Atorvastatin 40 mg). Primary Outcome: Changes in gut microbiota composition. Secondary Outcomes: Changes in blood lipid levels and inflammatory biomarkers.
3. Methods 3.1. Screening and Enrollment Participants are screened for eligibility based on inclusion and exclusion criteria.
After providing informed consent, participants are randomized into two groups (1:1 ratio) using a permuted block randomization method.
For those on prior statin or Ezetimibe therapy, a 2-week washout period is required before enrollment.
3.2. Study Medication
Participants receive their assigned treatment for 12 weeks, with medications administered orally once daily at consistent times, irrespective of meals:
High-Intensity Statin Group: Atorvastatin 40 mg. Combination Therapy Group: Atorvastatin 20 mg + Ezetimibe 10 mg. 3.3. Follow-Up Baseline data, including demographic details, blood tests, and stool samples, are collected at enrollment.
After 12 weeks of treatment, follow-up includes clinical evaluations, blood tests, and stool sample collection for post-treatment analysis.
4. Efficacy Evaluation 4.1. Primary Endpoint
Gut Microbiota Analysis:
Stool samples are analyzed using 16S rRNA sequencing.
Statistical tests compare microbiota differences:
Between groups at baseline (T-test or Mann-Whitney test). Pre- and post-treatment within groups (Paired t-test or Wilcoxon test). Intergroup changes over time (ANOVA test). 4.2. Secondary Endpoint Similar statistical methods are applied to assess changes in blood lipid levels and inflammatory biomarkers.
4.3. Subgroup Analysis
Specific subgroups undergo additional analysis:
Subgroup 1: Low-risk CAD patients (10-year ASCVD risk \<7.5%). Subgroup 2: Patients with poor response to therapy (LDL \>70 mg/dL after 12 weeks).
Subgroup 3: Recurrent CAD patients despite optimal therapy. Subgroup stool samples are analyzed using shotgun metagenomic sequencing for detailed microbial insights.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: