| CTRI Number |
CTRI/2024/07/070838 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness and safety of bempedoic acid and ezetimibe for treating high lipid levels |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy and safety of Bempedoic acid versus Ezetimibe in patients with Dyslipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Afzal Noor |
| Designation |
Junior Resident |
| Affiliation |
Eras Lucknow Medical College |
| Address |
Department of Pharmacology 5th floor Eras Lucknow Medical College Sarfarazganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8210934187 |
| Fax |
|
| Email |
mdafzalnoor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilshad Ali Rizvi |
| Designation |
Professor |
| Affiliation |
Eras Lucknow Medical College |
| Address |
Department of Pharmacology, 5th floor Eras Lucknow Medical College Sarfarazganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450025751 |
| Fax |
|
| Email |
dr.dilshadali@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Afzal Noor |
| Designation |
Junior Resident |
| Affiliation |
Eras Lucknow Medical College |
| Address |
Department of Pharmacology 5th floor Eras Lucknow Medical College Sarfarazganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8210934187 |
| Fax |
|
| Email |
mdafzalnoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eras lucknow medical college sarfarazganj lucknow Uttar Pradesh India 226003 |
|
|
Primary Sponsor
|
| Name |
Afzal Noor |
| Address |
Department of Pharmacology 5th floor, Eras Lucknow Medical College Sarfarazganj Lucknow India 226003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Afzal Noor |
Eras Lucknow Medical College |
Department of Pharmacology 5th floor
Lucknow
UTTAR PRADESH |
8210934187
mdafzalnoor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ELMCH Era University Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bempedoic acid |
Dose: 180 mg
Frequency: OD (once a day)
Route: Oral
Duration: 12 weeks |
| Comparator Agent |
Ezetimibe |
Dose: 10 mg
Frequency: OD (once a day)
Route: Oral
Duration: 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Stable atherosclerotic cardiovascular disease
Uncontrolled LDL cholesterol level (fasting more than 70 mg/dl) on maximally tolerated dose of statin.(Atrovastatin 80 mg OD, Rosuvastatin 40 mg OD)
|
|
| ExclusionCriteria |
| Details |
Age less than 18 yr
BMI more or equal 40 kg/m sq.
Triglyceride levels more or equal to 500 mg/dl
History of statin intolerance
History of cardiac event in last 12 weeks
Pregnant and Lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Achieving the target level of fasting LDL-C less than 70 mg/dl |
0 week 6 weeks 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study shall further examine the adverse drug reaction caused by Bempedoic acid 180 mg and Ezetimibe 10 mg in patients of dyslipidemia. |
0,6,12th weeks |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mdafzalnoor@gmail.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 29-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title : A Comparative study to evaluate the efficacy and safety of Bempedoic acid versus Ezetimibe in patients with Dyslipidemia Background : Dyslipidemia is characterized by an elevation of serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), or triglycerides (TG) and reduced serum high-density lipoprotein cholesterol (HDL-C) concentration. Bempedoic acid is a nonstatin for hypercholesterolemia. BA is ATP-citrate lyase inhibitor. It reduces hepatic cholesterol synthesis,which lead to clearance of LDL particles from circulation. Ezetimibe is a non-statin lipid-lowering medication that works by inhibiting the absorption of dietary cholesterol in the small intestine. MATERIAL AND METHODS: The study was conducted as a prospective, randomized, open-labeled trial at Era’s Lucknow Medical College and Hospital, with collaboration between the Department of Pharmacology and the Department of Medicine. A total of 106 patients participated, evenly distributed with 53 patients in each group. The study spanned a period of 18 months, during which patients with Atherosclerotic Cardiovascular Disease (ASCVD) and uncontrolled levels of Low-Density Lipoprotein Cholesterol (LDL-C), despite receiving the maximum tolerated dose of statin, were enrolled from the medical outpatient department of ELMC&H in Lucknow
|