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CTRI Number  CTRI/2019/04/018392 [Registered on: 02/04/2019] Trial Registered Prospectively
Last Modified On: 02/07/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Epidemiological Study 
Study Design  Single Arm Study 
Public Title of Study   Multi-center cross-sectional epidemiological study to understand the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease 
Scientific Title of Study   Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT03887520  ClinicalTrials.gov 
TQJ230A12001_Ver 0.0 dated 03-Oct-2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited, Medical Department, 6 & 7 floor, Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Scientific Query  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited, Medical Department, 6 & 7 floor, Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query  
Name  Murugananthan K 
Designation  Head-Clinical Development 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited, Medical Department, 6 & 7 floor, Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India

Mumbai (Suburban)
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, CH-4002 Basel, Switzerland. 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  Medical Dept, 6 & 7 floor, Inspire BKC G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai - 400051, Maharashtra 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Denmark
Egypt
Finland
France
Germany
Greece
Guatemala
Hong Kong
Hungary
Iceland
India
Israel
Italy
Japan
Jordan
Lebanon
Malaysia
Mexico
Netherlands
Norway
Peru
Philippines
Portugal
Republic of Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Viet Nam  
Sites of Study
Modification(s)  
No of Sites = 38  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajiv C  Amrita Institute of Medical Sciences & Research Centre  Clinical Research Division, Ponekkara P.O., Kochi - 682041, Kerala
Ernakulam
KERALA 		 9846562541

rajivc@aims.amrita.edu 
Dr Abraham Oommen  Apollo Hospitals  645 & 646, TH Road, Tondiarpet - Chennai, Tamil Nadu - 600081 IND
Chennai
TAMIL NADU 		 9841174578

drabrahamoomman@gmail.com 
Dr Subir Ghosh  Apollo Hospitals International Limited  Plot No.1A, Gandhinagar - Ahmedabad Road Bhat, GIDC Bhat, Estate, Ahmedabad, Gujarat 382424, India
Ahmadabad
GUJARAT 		 7698815045

drsubirghosh@rediffmail.com 
Dr Manjinder Sandhu  Artemis Hospitals  Sector-51, Gurgaon-122001, Haryana
Gurgaon
HARYANA 		 9818520234

manjinder@artemishospitals.com 
Dr Ajit Meha   Jehangir Clinical Development Center Pvt.Ltd.  Jehangir Hospital Premises 32 Sassoon Road,Pune-411001 
Pune
MAHARASHTRA 		 9552837558

startup@jcdc.co.in 
Dr A Ravikanth    Yashoda Hospital  Raj Bhavan Road,Somajiguda,Hyderabad-500 082,Telangana State,India
Hyderabad
TELANGANA 		 9849646335

athuluri113@gmail.com 
Dr Hemant Konkane  B.J. Govt. Medical College & Sassoon General Hospital   Department of Cardiology, Main Building, B.J. Govt. Medical College and Sassoon General Hospital, Near Pune Railway Station, Pune – 411001
Pune
MAHARASHTRA 		 9619294398

hemantkokane@gmail.com 
Dr Sandeep Patil  Bhaktivedanta Hospital and Research Institute  Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107
Thane
MAHARASHTRA 		 9324929490

drsandeep.patil@bhaktivedantahospital.com 
Dr Urmil Shah  CIMS Hospital  Off Science City Rd, Panchamrut Bunglows II, Sola, Ahmedabad, Gujarat 380060, India
Ahmadabad
GUJARAT 		 9825066939

urmil.shah@cims.me 
Dr Keshavamurthy C B   COLUMBIA ASIA HOSPITALS PRIVATE LIMITED  NO 85-86 BANGALORE-MYSORE RING ROAD ROAD JUNCTION BANNIMANTAPA A LAYOUT SIDDIQUI NAGAR MANDI MOHALLA MYSURU KARNATAKA 570015
Mysore
KARNATAKA 		 9900152852

cbkeshavamurthy@gmail.com 
Dr Gajendra Manakshe  Datta Meghe Institute of Medical Sciences(DU)  Jawaharlal Nehru Medical College, Acharya Vinobha Bhave Rural Hospital, Sawangi (Meghe), Wardha Maharashtra, India-442004
Wardha
MAHARASHTRA 		 9552212800

gajendramanakshe@gmail.com 
Dr Anil Jain  Epic Hospital   Sarkhej - Gandhinagar Hwy, opposite Kargil petrol pump, Sola, Ahmedabad, Gujarat 380081, India
Ahmadabad
GUJARAT 		 9825063284

dranilrjain@yahoo.co.in 
Dr Ajay Kumar Pandey  Galaxy Lifecare Services Pvt., Ltd.  Dayal Enclave, 4,5,6,7, Mahmoorganj Rd, Near Railway Station, Mahmoorganj, Varanasi, Uttar Pradesh 221010, India
Varanasi
UTTAR PRADESH 		 94152202323

dr.akpandeycardio@gmail.com 
Dr Neeraj Manikath  GOVERNMENT MEDICAL COLLEGE  KOZHIKODE 673008, KERALA INDIA
Kozhikode
KERALA 		 9447391055

drneerajmanikath@gmail.com 
Dr Tom Devasia  Kasturba Medical College and Hospital Department of Cardiology  Department of Medicine Manipal - Manipal, Karnataka - 576104 IND
Udupi
KARNATAKA 		 9448158508

tomdevasia@hotmail.com 
Dr Prafulla Kerkar  KEM Hospital & Seth G S Medical College  CVTC building, department of cardiology,Acharya Donde marg, Parel, Mumbai - 400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 9892362267

prafullakerkar@rediffmail.com 
Dr SK Dwivedi  King George’s Medical University  Lucknow-226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 9935037620

drskdwivedi60@gmail.com 
Dr Prasad M R  KLE DR PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTER  NEHRU NAGAR, BELAGAVI, KARNATAKA, 590010
Belgaum
KARNATAKA 		 9243245777

drpraadmr@gmail.com 
Dr Nagamalesh UM  M.S. Ramaiah Medical College and Hospitals  M.S. Ramaiah Clinical Research Centre, 1st floor, M.S. Ramaiah Advanced Learning Centre, M S Ramaiah Nagar, MSRIT Post Bangalore-560054, Karnataka, INDIA
Bangalore
KARNATAKA 		 9880135258

nmalesh@yahoo.co.in 
Dr BB Chanana  Maharaja Agrasen Hospital  West Punjabi Bagh, Near MGS Hospital, New Delhi, Delhi 110026
New Delhi
DELHI 		 9910109195

bbchanana@yahoo.com 
Dr Ranjan Shetty  Manipal Hospital  #98, HAL Airport Road, Bengaluru, Karnataka 560017, India
Bangalore
KARNATAKA 		 9243350978

ranjan.shetty@manipalhospitals.com 
Dr Sridhar Papani  Maxcure Hospitals  5 9 22 Secretariat Road - Hyderabad, Telangana - 500 063 IND
Hyderabad
TELANGANA 		 9490572735

seedhi139@gmail.com 
Dr Pankaj Harkut  Meditrina Institute of medical Sciences  Central Bazar Road, 278, Ramdaspeth, Nagpur-440010
Nagpur
MAHARASHTRA 		 9372723376

pankajharkut@rediffmail.com 
Dr Prashant Udgire   MGM hospitals  Ground floor , infront of blood bank , N6 cidco , Aurangabad , maharastra
Aurangabad
MAHARASHTRA 		 950181111

prashant_udgire@rediffmail.com 
Dr Nidheesh Mishra  New Era Hospital  Jalaram Mandir, Central Avenue Road, Near Telephone Exchange, Queta Colony, Lakadganj, Nagpur, Maharashtra 440008, India
Nagpur
MAHARASHTRA 		 9323078483

nidheeshmishra@gmail.com 
Dr Abhijeet Joshi  Niramaya hospital Pvt. Ltd  Chinchwad East, Post Office Road, Old Mumbai-Pune Highway, Pimpri- Chinchwad, Pune, Maharashtra- 411019
Pune
MAHARASHTRA 		 9823074846

dr.abhijeetjoshi@yahoo.com 
Dr Nirav Bhalani  Rhythm Heart Institute  Near Siddharth Bunglows Sama Savli Road - Vadodara, Gujarat - 390022 IND
Vadodara
GUJARAT 		 8128995863

trial@rhythmheart.com 
Dr DK Agarwal  S.P Medical College and A.G Hospitals  Haldiram Moolchand, Department of Cardiology, Bikaner- 334003
Bikaner
RAJASTHAN 		 9829217899

tippy1234@rediffmail.com 
Dr Sunil Sathe  Sahydri Super Speciality Hospital  Plot No.30-C,Erandwane,Karve Road,Pune-411004
Pune
MAHARASHTRA 		 9822030125

svscardcare@gmail.com 
Dr Monica Gupta  Samvedna Hospital  Durgakund Road Opp. IP Vijaya Mall, Bhelupur, Varanasi, Uttar Pradesh 221005, India
Varanasi
UTTAR PRADESH 		 9415336322

monicag4@yahoo.com 
Dr Sunil Karna  Shree Krishna Hospital and Medical Research Centre  Gokul Nagar - Karamsad, Gujarat - 388325 IND
Anand
GUJARAT 		 9712952029

sunilkk@charutarhealth.org 
Dr Tanuj Bhatia  Shri Mahant Indiresh Hospital  Kedarpur Village Rd, Industrial Area, Govt.Industrial Estate, Patel Nagar, Dehradun, Uttarakhand 248001, India
Dehradun
UTTARANCHAL 		 9936618283

tanujbhatia21@rediffmail.com 
Dr Ashwani Mehta  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi – 110060
New Delhi
DELHI 		 9811057384
1142251547
drashwanimehta@gmail.com 
Dr Pradeep Deshmukh  Super Speciality Hospital, Government Medical College and Hospital  Department of Cardiology, Tukdoji Square, Nagpur- 440009, Maharshtra
Nagpur
MAHARASHTRA 		 9823057346

pradeepti2001@yahoo.com 
Dr Padmanabh Jhinjuwadia  Sushri Jasumatiben Shahtilal Surti Charitable General Hospital  Shivranjani Char Rasta, Opp. Bima Nagar, Satellite, Ambavadi, Ahmedabad, Gujarat 380015, India
Ahmadabad
GUJARAT 		 9825890630

drpadmanabh@rediffmail.com 
Dr Vinod Vijan  Vijan Cardiac & Critical Care  Dr Vijan Hospital Marg, College Road, Nashik, Maharashtra 422005, India
Nashik
MAHARASHTRA 		 9822025353

dr.vijan.research@gmail.com 
Dr K Sarat chandra   Virinchi Hospital Institutional Ethics Committee  Virinchi Circle, Rd Number 1, Shyam Rao Nagar, Banjara Hills, Hyderabad, Telangana 500034, India
Hyderabad
TELANGANA 		 9848012212

saratkoduganti@gmail.com 
DrPrashanth  Yenepoya Medical College Hospital  Dept. of Internal Medicine, Yenepoya Medical College Hospital, Yenepoya University, University Road, Deralakatte, Mangalore - 575018, Karnataka, India"
Dakshina Kannada
KARNATAKA 		 9611777225

drprashathrm@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 42  
Name of Committee  Approval Status 
Artemis Health Sciences Institutional Ethics Committee  Submittted/Under Review 
 Ethics Committee,Jehangir Clinical Developement Centre Pvt.Ltd  Submittted/Under Review 
Bhaktivedanta Hospital ethics Committee  Approved 
Ethical Review Board   Submittted/Under Review 
Ethics commitee of shreeji Hospital,  Approved 
Ethics Committee of CIMS, Care Institute of Medical Sciences  Approved 
Ethics Committee of Manipal Hospitals  Submittted/Under Review 
Ethics Committee, Ramaiah Medical College and Hospitals  Approved 
Ethics Committee, S. P. Medical College & A. G. Hospital  Submittted/Under Review 
Galaxy Hospital Ethics Committee  Approved 
Institiutional Ethics Committee-Maxcure Hospitals  Submittted/Under Review 
Instituitional Ethics Committee-Clinical Studies  Submittted/Under Review 
Institutioanl Ethics Committee clinical studieds(IES-CS)Apollo Hospital International limited  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE   Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE, KLE Academy of Higher Education and Research  Approved 
Institutional Ethics Commitee Niramaya Hospitals Private Ltd .   Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE , GOVERNMENT MEDICAL COLLEGE  Submittted/Under Review 
Institutional Ethics committee Columbia Asia Hospital Mysore  Submittted/Under Review 
Institutional Ethics Committee Institutional Ethics Committee (IEC-I/II)   Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE LALITHA SUPERSPECIALITIES HOSPITAL  Approved 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre and Hospital, Dr. R BAlamurugan  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Datta Meghe Institute of Medical sciences  Submittted/Under Review 
Institutional Ethics Committee, Governement Medical College  Submittted/Under Review 
Institutional Ethics Committee, KIng Georges Medical University  Approved 
Institutional Ethics Committee, Shri Mahant Indiresh Hospital  Approved 
Institutional Ethics Committee, Yashoda Academy of Medical Education and Research  Submittted/Under Review 
Institutional Ethics Committee, Maharaja Agrasen Hospital  Submittted/Under Review 
INSTUTITIONAL ETHICS COMMITTEE, LISIE MEDICAL INSTITUTIONS  Approved 
Manipal University Ethics Committee  Submittted/Under Review 
Meditrina Institute Ethics Committee  Submittted/Under Review 
MGM Ethics Commitee for research omn human subjects (MGM-ECRHS)  Submittted/Under Review 
New Era Hospital Ethics Committee  Submittted/Under Review 
Research Society B.J.M.C. Pune  Submittted/Under Review 
Rhythm Heart Institute Ethics Committee  Submittted/Under Review 
Sahydri Hospitals Ltd Ethics Commitee   Approved 
Samvedna Hospital Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Submittted/Under Review 
Thakershy Charitable trust Ethics committee  Submittted/Under Review 
vijan hospital ethics commitee  Approved 
Virinchi Hospital Institutional Ethics Committee  Approved 
Yenepoya Research center   Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Signed informed consent must be obtained prior to participation in the study
2. Male and female ≥ 18 to ≤ 80 years of age
3. Established CVD defined as one of the following:
-History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study
visit
-History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
-Symptomatic PAD (intermitted claudication with ankle-brachial index 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the prevalence of normal and elevated Lp(a) levels in patients with established
CVD 		 One Day 
 
Secondary Outcome  
Outcome  TimePoints 
-To evaluate the median and other relevant
statistics describing the distribution of Lp(a) within
the normal range and elevated Lp(a) levels.
-To evaluate the median and other relevant
statistics describing the distribution of Lp(a) by
region and country
-To evaluate the median and other relevant
statistics describing the distribution of LDL-C
(corrected and uncorrected) within the normal
range and with elevated Lp(a) levels 		 One Day 
 
Target Sample Size   Total Sample Size="45000"
Sample Size from India="3250" 
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   N/A 
Date of First Enrollment (India)   30/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/04/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="21"
Months="8"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 Not Applicable. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This is a Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease. The purpose of this study is to To evaluate the prevalence of normal and elevated Lp(a) levels in patients with established CVD.

Target FPFV for India is 30-April-2019.

Sample size for India: 3250
 
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