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CTRI Number  CTRI/2025/02/081447 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Rosuvastatin plus Ezetimibe plus bempedoic acid versus statin  
Scientific Title of Study   Comparison of triple therapy (moderate intensity ROSuvastatin plus Ezetimibe plus bempeDoic acid) verus moderate to high intensity statin (ROSuvastatin) in patients with acute coronary syndrome. A first in world randomized ,single centre trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
RoBE/01/2024  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nagendra Boopathy S 
Designation  Professor of Cardiology 
Affiliation  Sri Ramachandra insttute of Higher education and Research 
Address  B1 First Floor SRIHER 1 Ramachandra Nagar Porur Chennai 600116
1 Ramachandra Nagar Porur Chennai 600116
Chennai
TAMIL NADU
600116
India 
Phone  04445928916  
Fax    
Email  drsnboopathy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagendra Boopathy S 
Designation  Professor of Cardiology  
Affiliation  Sri Ramachandra Institute of Higher Education 
Address  B1 First Floor SRIHER 1 Ramachandra Nagar Porur Chennai 600116
1 Ramachandra Nagar Porur Chennai 600116
Chennai
TAMIL NADU
600116
India 
Phone  04445928916  
Fax    
Email  drsnboopathy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nagendra Boopathy S 
Designation  Professor of Cardiology  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  B1 FIRST FLOOR SRIHER 1 Ramachandra Nagar Porur Chennai 600116
1 Ramachandra Nagar Porur Chennai 600116
Chennai
TAMIL NADU
600116
India 
Phone  04445928916  
Fax    
Email  drsnboopathy@gmail.com  
 
Source of Monetary or Material Support  
Sun Pharma Laboratories Limited Sun House Plot No. 201 B/1 Western Express Highway, Goregaon (East) Mumbai 400063 Maharashtra INDIA  
 
Primary Sponsor  
Name  Sun Pharmaceuticals 
Address  SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DRNAGENDRA BOOPATHY S  Sri Ramachandra Hospital   B1 Room No 5 first floor 1 Ramachandra Nagar Porur Chennai 600116
Chennai
TAMIL NADU 
04445928916

srmcclinicalresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC SRIHER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I999||Unspecified disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Rosuvastatin  Rosuvastatin -40mg once a day orally for 42 days 
Intervention  Rosuvastatin plus Ezetimibe plus BEmpedoic acid  moderate intensity rosuvastatin 20mg + bempedoic acid 180mg + ezetimibe 10 mg ( all once a day ) per oral x 42 days 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Age greater than 18 to 85 with acute coronary syndrome with LDL done within first 24
hour of ACS more than 100 mg% 
 
ExclusionCriteria 
Details  Patients with cardiogenic shock, end stage CKD, CLD, allergy to statins/ bempedoic acid or ezetimibe, hyperuricemia and those who will not provide informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean LDL at 6 weeks post initiation of therapy  6 weeks post initiation of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
% achieved target based on LAI, Mean TG reduction, mean non-HDL reduction, mean apo B-100 reduction, mean hs-CRP reduction, mean CPK level at 6 weeks, death or MI or repeat revascularization or stroke (MACE), and drug discontinuation rate

 
6 WEEKS 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/03/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
Study is ongoing after completion we will be working on publication 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Atherosclerotic Cardiovascular diseases (ASCVD) remains the major cause for mortality and morbidity globally1. World Health Organization reduce the burden of the same by 25% by 20251. An estimated 62.5 and 12.7 million years of life were lost prematurely in India and the United States, respectively that have been attributed to CVD.2  CVD contribute to 21-29% of total death in low middle countries.3  Currently, the best possible way to decrease atherosclerotic CVD (ASCVD) is to reduce LDL level , and controlling other traditional risk factors associated with ASCVD.4   The four pivotal ways to decrease LDL are

1.      Inhibiting HMG CoA reductase enzyme using statin therapy

2.      Inhibiting Citrate lyase using bEMPEDOIC ACID

3.      Inhibiting the Niemann-pick receptor using Ezetimibe

4.      Reducing the action of

PCSK 9 using antibodies ( alirocumab or everocumab ) or sn-RNA (inclisiran)

 

In the EPIC-STEMI study, it was shown that early initiation of PCSK9 inhibitors in addition to statin reduced LDL by 22% compared with sham injection5. Recently published PACMAN-AMI study found that patients who received alirocumab early after PCI (<24 hour)  for  AMI showed signficant reduction in plaque volume measured by IVUS, lipid-core index measured by NIRS, and improvement in fibrous cap thickness measured by OCT as compared with placebo.6   It was observed that nearly 80% of patients did not achieve  guideline-targeted lipid LDL levels within 90 days.7s Lipid testing during index hospitalization was associated in was with higher rates of initiation or escalation of statin therapy. within 90 days of their ACS. They also found that more than  33% would have been eligible for PCSK9 based therapy for achieving their goal.  Hence, the best time to treat them is during their index hospitalization. This will increase adherence, and also ensure proper reduction in LDL.7   Initiation of PCSK9 therapy for all patients with ACS will lead to higher LDL reduction which may translate to better clinical outcomes. In LMIC like India, the cost of PCSK9 therapy makes it beyond the reach of common man. Hence, we propose to study the safety and efficacy of  triple therapy to achieve early LDL reduction using moderate intensity statin plus ezetimibe plus bempedoic acid as compared to high intensity statin whose baseline LDL is more than 100.

 

 
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