| CTRI Number |
CTRI/2022/05/042446 [Registered on: 11/05/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
A Retrospective Real-World Evidence Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess LDL-C control (less than 55 mg/dL) in patients with ACS with current available treatments. |
|
Scientific Title of Study
|
Hypercholesterolemia in Acute Coronary Syndrome Patients in India - A Retrospective Real- World Evidence Study |
| Trial Acronym |
ACS Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CKJX839A1IN01, Version number-V1.0, Dated-23-02-2022 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Kimi Shetty |
| Designation |
Medical Lead |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Inspire BKC, G Block, 6th & 7th Floor, BKC Main Road,
Bandra Kurla Complex, Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8097345284 |
| Fax |
|
| Email |
kimi_kishore.shetty@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venugopal Madhusudhana |
| Designation |
VP Research |
| Affiliation |
Sekhmet Technologies Pvt. Ltd |
| Address |
A Plot No. 7(2 bays), Urban Estate, Opposite Jet Airways Training Center, Sector 32
Gurgaon
HARYANA
122001
India |
| Phone |
7738371973 |
| Fax |
|
| Email |
venugopal@thb.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venugopal Madhusudhana |
| Designation |
VP Research |
| Affiliation |
Sekhmet Technologies Pvt. Ltd |
| Address |
A Plot No. 7(2 bays), Urban Estate, Opposite Jet Airways Training Center, Sector 32
Gurgaon
HARYANA
122001
India |
| Phone |
7738371973 |
| Fax |
|
| Email |
venugopal@thb.co.in |
|
|
Source of Monetary or Material Support
|
| Novartis Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Inspire BKC, G Block, 6th & 7th Floor, BKC Main Road, Bandra Kurla Complex, Bandra (East) Mumbai - 400051
Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Gupta |
Cardium Clinic |
Dept. Of cardiology, ground floor,CARDIUM ADVANCED HEART CARE CLINICK, Intercity CHS,Sector-16,Vashi,Navi Mumbai,Maharashtra 400703
Mumbai
MAHARASHTRA |
9619597754
drrahul.gupta@hotmail.com |
| Dr Rajagopal jambunathan |
Cauvery Heart & Multispecialty Hospital |
Dept. Of cardiology, Malavalli - Mysore Rd, Near Teresian College, Siddhartha Layout, Mysuru, Karnataka 570011
Mysore
KARNATAKA |
9980298321
rajagopalj@gmail.com |
| Dr Madhur Jain |
Dr. Madhur Jains Clinic |
22/203, Eastend Apartment, Mayur Vihar
Phase 1 Extn. New Delhi 110096
New Delhi
DELHI |
9818605568
dr.madhurjain1@gmail.com |
| Dr Rahul Dadasaheb Sawant |
Hridaymitra Cardia Clinic |
1st Floor, Pushpa Prestige, Opposite City Pride
Cinema, Pune Satara Road, Pune, Maharasthra-411009
Pune
MAHARASHTRA |
7875025656
drrahulsawant@hotmail.com |
| Dr Sunil Modi |
Indraprastha Apollo Hospital |
lndraprastha Apollo Hospital, Mathura Road,
Sarita Vihar, Jasola, New Delhi- 110025
New Delhi
DELHI |
9811043487
skmnewdelhi@gmail.com |
| Dr Anand Subramaniyan |
Kauvery Heart City |
No. 1, Alexandriya Road, Cantonment, Tiruchirapalli, Tamil
Nadu-620001
Tiruchirappalli
TAMIL NADU |
7708867791
anandsubbu81@yahoo.co.in |
| Dr Ajit Mullassari |
Madras Medical Mission Hospital, Chennai |
Dept. Of cardiology,1 floor, 4-A, Dr, Mogappair, Chennai, Tamil Nadu 600037
Chennai
TAMIL NADU |
9841271361
sulu_ajit57@yahoo.co.in |
| Dr Nakul Sinha |
Medanta Hospital |
Sector - A, Pocket - 1, Amar Shaheed Path, Golf
City, Lucknow, Uttar Pradesh 226030
Lucknow
UTTAR PRADESH |
9919002760
sinha.nakul@gmail.com |
| Dr Anupam Jena |
Restora Healthcare |
Flat No 32, GA 190, Yasoda Homes, Patia,
Bhubaneswar, Odisha 751024
Khordha
ORISSA |
9078828539
dranupamjena@gmail.com |
| Dr Hitanshu R Panchal |
Savita Superspeciality Hospital |
Parivar Char Rasta, Waghodia Dabhoi Ring
Road, Vadodara-390019.
Vadodara
GUJARAT |
9662090655
panchalhitanshu@gmail.com |
| Dr AM Karthik Kumar Dos |
Smile Health Clinic |
708- 709, VKK Menon road, Siddhapudur, Coimbatore- 641044
Coimbatore
TAMIL NADU |
9952269805
karthikdos@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Madaras Medical Mission |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged >18 years. 2. Patients with ACS event [One or more of the following: ST-segment-elevation myocardial infarction or left bundle branch block myocardial infarction (STEMI/LBBB MI), a non-ST-segment-elevation myocardial infarction (NSTEMI), or UA with or without PCI/ CABG. 3. Lipid profile data available at index date/15 days of index date and at least once at 3, 6, 9, 12 months post-index date ACS event. |
|
| ExclusionCriteria |
| Details |
Patients meeting any of the following criteria will not be included in the study: 1. Incomplete paper-based records/EMRs data. 2. Non-availability of paper-based records/EMRs for 12 months’ time point post index date ACS event. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess LDL-C control (less Than 55 mg/dL) in patients with ACS with current available treatments |
Time Frame: Baseline, Months 3, 6, 9, and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
In patients with ACS with current available treatments
A. To Assess LDL-C control (Less Than 30, Less Than 50, Less than 70, Less Than 100 mg/dL) B. To assess Lp(a) testing and control C. To study the change in lipid profile parameters D. To assess treatment pattern of statin positive or negative, other lipid lowering drugs, statin intolerance E. To assess tolerability-of LLTs F. To assess demographic profile, clinical characteristics, and concomitant medications |
A. Proportion of ACS patients achieving LDL-C goal at 3, 6, 9, and 12 Months after index date of CS event B. Proportion of ACS patients who underwent Lp(a) testing C. Change in lipid profile parameters in 3, 6, 9, and 12 months D. treatment pattern of statin, other lipid lowering drugs, statin intolerance at 3, 6, 9, 12 months E. Proportion of ACS patients who reported AE F. Clinical characteristics of ACS patient and various concomitant medications at baseline |
|
|
Target Sample Size
|
Total Sample Size="558"
Sample Size from India="558"
Final Enrollment numbers achieved (Total)= "575"
Final Enrollment numbers achieved (India)="575" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
06/06/2022 |
| Date of Study Completion (India) |
09/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
the results of this non-interventional study may be either submitted for publication and/or posted in a publicly accessible database of results. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Cardiovascular disease (CVD) is leading cause of death worldwide, accounting for about 31% of global death (WHO, 2018) 2. In India, CVD is responsible for about 27% of all deaths (WHO, 2018) 3. Atherosclerosis cardiovascular disease (ASCVDs) are associated with a substantial mortality, physical morbidity, and mrtal disability. India has been experiencing an epidemic of ASCVD, which has suppressed infectious diseases as the leading cause of death among Indians. Elevated plasma low-density lipoprotein cholesterol (LDL-C) level play a major role in the pathophysiology of ASCVDs ( Auer and Berent,2018) 4. No major study exists currently that could hlep identify the level of LDL-C control amongst Indian acute Coronary syndrome (ACS) patients, especially as per the revised LAI consensus and other global guidelines. 5. The present study is therefore being conducted to evaluate the real world experience related to the treatment patterns and LDL-C control in ACS patients. |