| CTRI Number |
CTRI/2025/03/082077 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [METABOLIC/LIPID PROFILE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Bempedoic acid added to statin therapy vs statin monotherapy in lowering the remnant cholesterol |
|
Scientific Title of Study
|
A study to compare the effect of Bempedoic acid added to statin therapy vs statin monotherapy in lowering the remnant cholesterol in established Atherosclerotic cardiovascular disease(ASCVD) patients: A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin J Dhas K S |
| Designation |
Junior resident |
| Affiliation |
SRM Medical College Hospital and Research Center |
| Address |
Room 502 , Apj Abdul Kalam Gents Hostel, SRM Medical College Hospital and Research Centre,Kattankulathur,Chengalpattu District, 603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9442510179 |
| Fax |
|
| Email |
ashwinjdhas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J S KUMAR |
| Designation |
Professor and HOD(General medicine) |
| Affiliation |
SRM Medical College Hospital And Research Center |
| Address |
Department of General Medicine , SRM Medical College Hospital and Research Centre,Kattankulathur,Chengalpattu District, 603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9840047678 |
| Fax |
|
| Email |
kumarj1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin J Dhas K S |
| Designation |
Junior resident |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room 502 , APJ Abdul Kalam Gents Hostel, SRM Medical College Hospital And Research Centre,Kattankulathur,Chengalpattu District, 603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9442510179 |
| Fax |
|
| Email |
ashwinjdhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre,Kattankulathur,Chengalpattu District,Tamil Nadu,India, 603203 |
|
|
Primary Sponsor
|
| Name |
Dr Ashwin J Dhas K S |
| Address |
Room 502 , Apj Abdul Kalam Gents Hostel, SRM Medical College Hospital and Research Centre,Kattankulathur,Chengalpattu District, 603203 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwin J Dhas K S |
SRM Medical College Hospital and Research Centre |
SRM Medical College Hospital and Research Centre,Kattankulathur,Chengalpattu District, 603203
Chennai
TAMIL NADU |
9442510179
ashwinjdhas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: I252||Old myocardial infarction, (3) ICD-10 Condition: I258||Other forms of chronic ischemic heart disease, (4) ICD-10 Condition: I509||Heart failure, unspecified, (5) ICD-10 Condition: I639||Cerebral infarction, unspecified, (6) ICD-10 Condition: I709||Other and unspecified atherosclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bempedoic acid with Maximum Tolerated dose of statins |
Bempedoic acid 180 milligrams once daily, oral route for 90 days.
Statins- maximum tolerated dose, once daily, oral route for 90 days |
| Comparator Agent |
maximum tolerated dose of statins |
maximum tolerated dose of statins once daily for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with established ASCVD on statins
2)LDL cholesterol of more than 55 mg/dl
|
|
| ExclusionCriteria |
| Details |
1)Patients without established ASCVD
2)Patients not on statins
3)Lactating breastfeeding mothers
4)LDL cholesterol of less than 55 mg/dl
5)patients already on bempedoic acid
6)Patients on other anti-lipidemic drugs other than statins
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the effect of bempedoic acid in lowering the remnant cholesterol |
DAY 0 AND DAY 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of bempedoic acid on other components of lipid profile,Apolipoprotein B and HsCRP |
DAY 0 AND DAY 90 |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2025 |
| Date of Study Completion (India) |
30/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STUDY JUSTIFICATION: • Recent studies have shown that elevated levels of remnant cholesterol was associated with an increased risk of ASCVD • Bempedoic acid has been shown effectively lower ldl levels not controlled with high intensity statins alone. • This interventional study is being done to establish the effect of bempedoic acid in lowering the remant cholesterol level
STUDY DESIGN- An open label randomized controlled trial
SAMPLE SIZE:88 (44 in each group)
METHODOLOGY : • Select patients fitting the inclusion criteria • Measure the lipid profile and calculate the remnant cholesterol levels(remnant cholesterol= total cholesterol – [LDL cholesterol+HDL cholesterol] at baseline. • Patients were randomized 1:1 to treatment with bempedoic acid (180 mg) once daily for 12 weeks in the intervention group • Remnant cholesterol in measured at day 0 and day 90 • Apolipoprotein B is measured at day 0 and at day 90 • HsCRP measured at day 0 and day 90
|