| 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
|
|
|
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
|
|
|
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.
|