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CTRI Number  CTRI/2014/02/004387 [Registered on: 07/02/2014] Trial Registered Prospectively
Last Modified On: 13/06/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With SAR236553 (REGN727) 
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome 
Trial Acronym  ODYSSEY Outcomes 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
EFC11570- Protocol Amend. 06 version02 dated 05-Dec-2013  Protocol Number 
NCT01663402  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Denis Xavier  
Designation  Professor and Head, Dept. of Pharmacology,  
Affiliation  St. Johns Medical College 
Address  St. Johns Medical College Head, Division of Clinical Research and Training, St. Johns Research Institute St. Johns National Academy of Health Sciences Bangalore 560 034, India

Bangalore
KARNATAKA
560034
India 
Phone  8049466140  
Fax  8025633382  
Email  drdenisxavier@hotmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Vaibhav Salvi 
Designation  Medical advisor 
Affiliation  Sanofi Synthelabo India Limited 
Address  SANOFI-SYNTHELABO (I) Private Limited, Sanofi House, CTS No. 117-B, L&T Bussiness Park, Saki Vihar Road, Powai,Mumbai – 400 072, INDIA

Mumbai
MAHARASHTRA
400072
India 
Phone  02228032820  
Fax    
Email  Vaibhav.Salvi@sanofi.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Rajiv De 
Designation  Team Leader  
Affiliation  Sanofi Synthelabo India Limited 
Address  SANOFI-SYNTHELABO (I) Private Limited, Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Mumbai- 400 072, INDIA

Mumbai
MAHARASHTRA
400072
India 
Phone  02230707830  
Fax    
Email  rajiv.de@sanofi.com  
 
Source of Monetary or Material Support
Modification(s)  
SANOFI-SYNTHELABO (I) Private Limited, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai– 400 072, INDIA  
 
Primary Sponsor
Modification(s)  
Name  Sanofi Synthelabo India Private Limited 
Address  Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai Mumbai – 400 072, INDIA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belarus
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Denmark
Estonia
Finland
France
Germany
Hong Kong
Hungary
India
Israel
Italy
Latvia
Lithuania
Malaysia
Mexico
Netherlands
New Zealand
Norway
Peru
Philippines
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Serbia
Singapore
Slovakia
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 64  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunil Shirikumar Thanvi  B&M Patel Cardiac Centre  Shree Krishna Hospital and Medical Research Centre,Gokalnagar- 388325, Gujarat
Anand
GUJARAT 
9825012296

ssthanvi@yahoo.com 
DrPrasant Bhansali  AMC MET Medical college and L. G. Hospital  S.G Hospital & Amc Met Medical College rambag Manin nagar Ahmedabad-380008 Gujarat
Ahmadabad
GUJARAT 
9426417678

drpbhansali@yahoo.com 
Dr Abraham Oomman  Apollo Hospitals  21,Greams Lane,Off Greams Road, Thousand Lights Chennai Tamilnadu 600006 India
Chennai
TAMIL NADU 
4428295045
4428294449
drabrahamoomman@gmail.com 
Dr Manjinder Singh Sandhu  Artemis Health Institute  Sector-51, Gurgaon-122001, Haryana, India
Gurgaon
HARYANA 
9818520234

manjinder@artmishealthsciences.com 
DrGirish Chandrakant Rajadhyaksh  B Y L Nair Ch. Hospital and T N Medical College  104, Department of medicine, first floor TN. Medical College and BYL Nair Hospital Dr. Ar Nair Road, Mumbai Central Mumbai
Mumbai
MAHARASHTRA 
02223027122

girishraj63@gmail.com 
Dr Dhiman Kahali  B. M. Birla Heart Research Centre  1/1 National Library Avenue Kolkata, west Bengal
Kolkata
WEST BENGAL 
33-24567006

kahalidrdhiman@gmail.com 
Dr Kartikeya Parmar   B.J. Medical College & Civil Hospital  Department of Medicine,Asarwa, Ahmedabad – 380016, Gujarat
Ahmadabad
GUJARAT 
9924643799
91-79-22683091
drkartik@gmail.com 
Dr Santanu Guha  Calcutta Medical College and Hospital  Department of Cardiology 88,College Street Kolkata 700073 West Bengal
Kolkata
WEST BENGAL 
9831016367

Guhas55@gmail.com 
Dr Surya Prakash Gulla  Care Hospital  Near Clock tower,Market street, Secunderabad Andhra Pradesh 500003
Hyderabad
ANDHRA PRADESH 
4030114555

suryaprakashgulla@gmail.com 
Dr Bagirath Raghuraman  Chinmaya Narayana superspecility hospital  CMH Road, Chinmaya Mission hospital complex, Indira Nagar bANGALORE - 560038, Karnataka
Bangalore
KARNATAKA 
8025200002
8025200927
bagirath.raghuraman.dr@nhhospitals.org 
Dr Chopada Manojkumar Bhavarilal  Chopda Medicare & Research Centre Pvt. Ltd  Magnum Heart Institute, Patil Lane 1, Near K.B.H. Vidhyala, Canada Corney, Nashik- 422 005, Maharashtra, India
Nashik
MAHARASHTRA 
9823021613

rush_manoj@yahoo.com 
Dr Khan Mohd Aziz   Crescent Hospital & Heart Centre  Near Lokmat Square, Behind Old Mount Carmel School, Dhantoli, Nagpur-440012, Maharashtra
Nagpur
MAHARASHTRA 
9823056551

khandraziz@yahoo.com 
Dr Gajendra Manakshe   Datta Meghe Institute of Medical sciences  Jawaharlal Nehru Medical college, Wardha-442 004, Maharashtra, India
Wardha
MAHARASHTRA 
9552212800

gajendramanakshe@gmail.com 
Dr Shireesh Prabhakar Sathe  Deenanath Mangeshkar Hospital & Research Centre  Erandwane, Near Mhatre Bridge, Pune – 411004, Maharatra
Pune
MAHARASHTRA 
9822053216
91-20-25466584
shireesh.sathe@gmail.com 
Dr Jitendra Pal Singh Sawhney   Dharma Vira Heart Center, Sir Ganga Ram Hospital  Sir Ganga Ram Hospital Marg, Rajinder Nagar, Ned Delhi-110060
New Delhi
DELHI 
1142437230

jpssawhney@yahoo.com 
Dr Ramesh Pothineni  Dr. Ramesh Cardiac & Multispeciality Hospital Pvt. Ltd  Ring Road, Near ITI College Vijayawada Andhra Pradesh 520008 India
Vizianagaram
ANDHRA PRADESH 
8662484800

dr_rameshbabu_p@yahoo.co.in 
Dr Rajeev Gupta  Fortis Escorts Hospital  Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur – 302017, Rajasthan
Jaipur
RAJASTHAN 
9829114086
91-141-4008151
rajeevgg@gmail.com 
Dr Keshava Ramaiah  Fortis Hospital  No. 14, Cunningham Road, Sheriffs Chamber Bangalore Karanataka 560052 India
Bangalore
KARNATAKA 
8041994444
8022281149
rkeshava@hotmail.com 
Dr Sanjeev Chaudhary  Fortis Memorial Research Institute  Sector 44, Opp. Huda City Centre Metro Station, Gurgaon, 122002, Haryana
Gurgaon
HARYANA 
1244962200

drsanjeevcardio@gmail.com 
Dr Nagasri Haritha  Haritha Guntur Medical college Guntur  Department of cardiology Guntur Medical College & Government General Hospital,near railway station Guntur-522004, Andhra Pradesh, India
Guntur
ANDHRA PRADESH 
9705914488

drharithan@gmail.com 
Dr Sreemannarayana J  Heart and Brain Institute  Heart and Brain Institute, Andhra Hospitals, Vijayawada- 520002, Andhra Pradesh
Krishna
ANDHRA PRADESH 
8662442333

maheshfulwani@yahoo.co.in 
Dr Sujatha Vipperla  Indus Hospital  Indus Hospital KGH Down Road, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 
8912768881

sujasri@hotmail.com 
Dr D P Sinha  IPGME&R SSKM Hospita  244, Acharya Jagadish Vhandra Bose Road, Kolkata, west Bengal, India-700020
Kolkata
WEST BENGAL 
9433018443

drdpsinha@gmail.com 
Dr Priya Palimkar  Jehangir Clinical Development Centre Pvt. Ltd  Jehangir Hospital premises, 32 Sassoon Road, Pune-411001, Maharashtra, India
Pune
MAHARASHTRA 
9270043039

drpriyapalimkar@gmail.com 
Dr Prafulla Kerkar  K.E.M Hospital & Seth G.S Medical College, Department of Cardiology  Department of Cardiology, K.E.M Hospital & Seth G.S Medical College,CVTC Building 4th Floor, Acharya Donde Marg,Parel Mumbai Mumbai,Maharashatra 400012 India
Mumbai
MAHARASHTRA 
9820144111
022024116732
prafullakerkar@rediffmail.com 
Dr Ravishankar Airody   K.R.Hospital  Opp. Mysore Medical College and Research Institute,Irwin Road Mysore KARNATAKA 570001
Mysore
KARNATAKA 
8212420142

airodyravishank@yahoo.co.in 
Dr Ajit Bhagwat  Kamal Nayan Bajaj Hospital  Kamal nayan Bajaj Hospital, Situated at GUT.NO.43, Satara Parisar, Bajaj Marg, Beed By-Pass Road, Aurangabad-431005, Maharashtra, India
Aurangabad
MAHARASHTRA 
02402377999

drbhagwat.knb@gmail.com 
Dr Umesh Bilagi  Karnataka Institute of Medical Sciences  P.B.Road Vidyanagar, Hubli, Karnataka - 580022
Hassan
KARNATAKA 
9343403620

umeshbilagi@gmail.com 
Dr Kalashetti Suhas  KEM Hospital Research Centre  KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, Pune,Maharashtra, India
Pune
MAHARASHTRA 
8805387387

skalashetti@yahoo.com 
Dr Sanjay Porwal  KLES, Dr. Prabhakar Kore Hospital and Medical Research Centre  KLES, Dr. Prabhakar Kore Hospital and Medical Research Centre, Belgaum-590010, Karnataka, India.
Belgaum
KARNATAKA 
9323033639

drsanjayporwal@gmail.com 
Dr Aparna Patange   Krishna Institute of Medical Sciences  Krishna Institute of Medical Sciences Deemed University, Karad (IEC-KIMSDU), Near Dhebewadi Road, Malkapur Tal. – K arad 415539, Maharashtra
Satara
MAHARASHTRA 
9881281829

aparnapatange@gmail.com 
Dr Rajendra Kumar Premchand  Krishna Institute of Medical Sciences Ltd  1-8-31/1, Minister Road, Secunderabad – 500003, Andhra Pradesh
Hyderabad
ANDHRA PRADESH 
9848029443
91-40-40045215
kumarpre@hotmail.com 
Dr Jabir Abdulla kutty  Lisie Hospital  Lisie Hospital Cochin 682018 Kerala
Ernakulam
KERALA 
4842402044

drjabi@yahoo.co.in 
Dr Sudhir R Pawar  Lokamanya Tilak Medical General hospital  Lokmanya Tilak Municipal Medical College & general Hospital 2nd Floor , Room No. 17,Dr.B R Ambedkar road Sion Mumbai- 400022
Mumbai
MAHARASHTRA 
02224090446
02224081038
dr.sudhirpawar@gmail.com 
Dr V S Prakash  M.S.Ramaiah Narayana Hrudhayalaya Heart Center, MS Ramaiah Medical College and Hospitals  New BEL Road, MSRIT Post, Bangalore – 560054, Karnataka
Bangalore
KARNATAKA 
9844033964
91-80-23601983
drprakashvs@gmail.com 
Dr Nitin Patki  Maharashtra Medical Research Society Joshi Hospital  Maharashtra Medical Research Society, 778, Shivaji Nagar, Pune 411004
Pune
MAHARASHTRA 
02025676861

nitinpatki@gmail.com 
Dr Yerra Shiva Kumar  Mahavir hospital & Research Centre  10-1-1, Bhagwan Mahavir Marg, A.C. Guards,masak tank Hyderabad A.P
Hyderabad
ANDHRA PRADESH 
19000700171

shivakumar.yerra@gmail.com 
Dr Shamanna Iyengar  Manipal Hospital  Manipal Hospitals at Manipal Hospital, #98, HAL Airport Road, Bangalore,
Bangalore
KARNATAKA 
8025024255

shamiyengar@airtelmail.in 
Dr Naresh Kumar Goyal  Max Super Speciality Hospital  Max Healthcare Super Speciality Hospital, FC 50, C & D Block, Shalimar Bagh,New Delhi-110017
New Delhi
DELHI 
011-66422222

drnaresh.goyal@maxhealthcare.com 
Dr Sumeet Sethi  Max Super Specialty Hospital  2, Press Enclave Road, Saket, New Delhi - 110017
New Delhi
DELHI 
9899690609
91-11-26515060
sumeet.sethi@maxhealthcare.com 
Dr Vijay Kumar Chopra  Medanta The Medicity  Sector 38, Gurgaon – 122001, Haryan
Gurgaon
HARYANA 
9560398900
91-124-4834468
VK.Chopra@Medanta.org 
Dr Regella Prasad Reddy  Mediciti Hospitals  5-9-22,Secretariat Road Hyderabad-50063, A.P
Hyderabad
ANDHRA PRADESH 
04023299078
040-23231111
drprasadreddy@yahoo.com 
Dr Pankaj Harkut  Medttrina Institute of Medical Sciences  278,Central Bazar Road, Ramdaspeth, nagpur - 440010, Maharashtra
Nagpur
MAHARASHTRA 
7126669666

info@meditrinainstitute.com 
Dr S Selvamani  Meenakshi Mission Hospital and Research Centre  Meenakshi Mission Hospital and Research Centre, Madurai – 625107 Tamilnadu , India
Madurai
TAMIL NADU 
9842158868

maniselva@hotmail.com 
Dr Srihari Das Kesavan Purushothaman   NH-Narayana Multispecialty hospital  Site # 1, 18th Main (Opp HSR club, Sector III, HSR layout, Bangalore- 560102, Kolkata
Bangalore
KARNATAKA 
8071112224

dr.srihari@gmail.com 
Dr Abhijeet Bhaskar Joshi  Niramaya Hospital  Survey No. 4742, Behind Jai Hind Petrol Pump,Next to Chinchwad East Post Office, Chinchwad, Pune-411019, Maharashtra India
Pune
MAHARASHTRA 
2027441860
2027441865
niramayachinchwad@niramayahospital.com 
Dr Atul Damodar Abhyankar   Nirmal Hospital Pvt Ltd.  Nirmal Hospital Pvt Ltd,Ring Road, Surat, Gujurat India
Surat
GUJARAT 
2613072829

atulda@hotmail.com 
Dr Rahul Patil  Noble Hospital  Dept. of Cardiology, 153, Magarpatta City Road, Hadapsar Pune Maharashtra 411013
Pune
MAHARASHTRA 
020-66285000

dr.prahulresearch@gmail.com 
Dr Mukund Kumbla  OMEGA Hospital  Mahaveer Circle, Kankanady Mangalore - 575002, Karnataka, India
Bangalore
KARNATAKA 
9845082811

drmukund@epsilon.net.in 
Dr Bhaskara Rao Malipeddi  Queens NRI Hospital  Gurudwara Lane, Seethammadhara, Vishakhapatnam – 530013, Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH 
9246624766
91-891-2764766
bhaskarstudies@hotmail.com 
Dr Ratan Lal Ranka  S P Medical College and AG Hospitals  Bikaner – 334001, Rajasthan
Bikaner
RAJASTHAN 
9414242878
91-151-2525451
drrankamdspmc@yahoo.com 
Dr Rishabh Mathur  S. R. Kalla Memorial Gastro & General Hospital  78, Dhuleshwar Garden Behind HSBC Bank, Sardar Patel Marg, C-Scheme, Jaipur-302001, Rajasthan
Jaipur
RAJASTHAN 
9571320908

rishabhmathur13@yahoo.com 
Dr Vijay Pathak  S.M.S. Medical College  S.M.S. Medical Hospital, J.L.N. Marg, Jaipur – 302004
Jaipur
RAJASTHAN 
9829052082

drvijaypathaksms@gmmail.com 
Dr Rituparna Shinde  Sanjeevan Hospital  Sanjeevan Hospital Plot no. 23, Off Karve Road, Erandavne, Pune-411004
Pune
MAHARASHTRA 
02067250000

ritushinde@gmail.com 
Dr Rohidas Borse  Sassoon Hospital  Dept. of Pharmacology, BJ Govt. Medical College, Sassoon Road, Pune - 411001
Pune
MAHARASHTRA 
9923912525

drborser@gmail.com 
Dr Jasprakash Singh Grewal  Satguru Pratap Singh Apollo Hospitals  Sherpur Chowk, Ludhiana-141003, Punjab, India.
Ludhiana
PUNJAB 
161-6617171
161-6617111
jasprakashgrewal@hotmail.com 
Dr Bhupesh shah Rajnikant  Seth Vadilal sarabhai general hospital  Dept. of Pharmacology, First Floor, Smt. NHL, Municipal Medical College, Ellisbridge, Ahmedabad 380006 Gujarat
Ahmadabad
GUJARAT 
9825032282

shahbhupesh@hotmail.com 
Dr Mahesh Chandulal Fulwani  Shrikrishna Hrudayalaya and Critical Care Centre  Shrikrishna Hrudayalaya and Critical Care Centre, Tikekar Road, Congress Nagar Square, Dhantoli, Nagpur-440012, Maharashtra, India
Nagpur
MAHARASHTRA 
8662442333

drsreemantrials@gmail.com 
Dr Vengatesh Munusamy   SRM Medical College Hospital And Research Centre  Kattankulathur, Kancheepuram channai- 603203, Tamil nadu
Chennai
TAMIL NADU 
4447432342
4447000000
cardioresearch.srm@hotmail.com 
Dr Srilakshmi Adhyapak  St John’s Medical College & Hospital   St John’s Medical College & Hospital sarjapur road Bangalore-560034
Bangalore
KARNATAKA 
8025633087

srili2881967@gmail.com 
DR Sharath Annam  Sunshine Hospitals  Behind Paradise Hotel, Penderghast Road,Opp. Parsi Dharamsala Secunderabad Andhra Pradesh 500003 India
Hyderabad
ANDHRA PRADESH 
40-64636363

drsharathdm@gmail.com 
Dr Ulhas Madhukar Rao Pandurangi  The Madras Medical Mission  A, Dr J Jayalalitha Nagar, Mogappair, Chennai – 37, Tamil Nadu
Chennai
TAMIL NADU 
9841273868
91-144-26565943
clinicalresearchmmm@gmail.com 
Dr Rufino Monteiro  Vintage Hospital & Medical Research Centre  Vintage Hospital and Medical Research Center Caculo Emclave St. Inez. Panaji 403001 Goa India
North Goa
GOA 
08326711541

cromgoa@gmail.com 
Dr Mohanan Padinhare  Westfort Hi-Tech Hospital  Westfort Hi-Tech Hospital" Department of Cardiology, Post Box No. 930, Punkunnam"Thrissur Kerala 680002 India
Thrissur
KERALA 
4872388999

drppmohanan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 57  
Name of Committee  Approval Status 
AMC Met EC/ Ahmedabad/Dr Prasant Bhansali  Approved 
Apollo Hospitals InstitutionalEC/Chennai/Dr Abraham Oomman  Approved 
ApolloEC_Ludhiana_DrGrewal  Approved 
B.M. Birla Heart Research Centre Institutional Ethics Committee  Submittted/Under Review 
BJ Govt Medical College and Sassoon Government Hospital EC/ Pune/Dr Rohidas Borse  Submittted/Under Review 
Care Hospital Care Convergence Centre EC/ Hyderabad/Dr Surya Prakash  Approved 
Chopda Medicare & Research Centre Pvt. Ltd., Magnum Heart InstituteEC/Nashik/Dr. Chopada Manojkumar Bhavarilal  Submittted/Under Review 
Crescent HospitalEC/Nagpur/Dr. Khan Mohd Aziz   Submittted/Under Review 
Datta Meghe Institute of Medical ScienceEC/Wardha/Dr.ajendra Manakshe  Submittted/Under Review 
DeenanathMangeshkarHospital & ResearchCentreEC_Pune  Submittted/Under Review 
Dr Ramesh Cardiac Multispeciality Hospital Ltd EC/ Vijayawada/Dr Ramesh Babu Pothineni  Approved 
Fortis Hospital EC/Bangalore/Dr.Keshava Ramaiah  Approved 
FortisEscortsHospitalEC_Jaipur_DrRajeevGupta  Approved 
Indus Hospital EC/ Vishakhapatnam/Dr Sujatha Vipperla  Approved 
Institutional EC Artemis Health Institute/Gurgaon/Dr.Manjinder Singh Sandhu  Submittted/Under Review 
Institutional EC for Human Research/ Kolkata/Dr Santanu Guha  Approved 
Institutional ECAndhra Hospital/Vijayawada/Dr. Sreemannarayana J  Submittted/Under Review 
Institutional Ethics Committee-HM Patel Centre For Medical Care and Education Karamsad-Dr Sunil Karna  Approved 
InstitutionalEC/Fortis Memorial Research Institute/Gurgaon/Dr. Sanjeev Chaudhary  Submittted/Under Review 
InstitutionalECfor Biomedical Research  Approved 
IPGME&R Institutional EC/ Kolkata/Dr D P Sinha  Approved 
Jehangir Clinical Development Centre Pvt. LtdEC/Pune/Dr. Priya Palimkar  Submittted/Under Review 
K.E.M Hospital & Seth G.S.Medical College/Mumbai/Dr Prafulla Kerkar  Submittted/Under Review 
Kamalnayan Bajaj HospitalEC/ Aurangabad/ Dr Ajit Bhagwat  Submittted/Under Review 
Karnataka Institute of Medical Sciences/Hubli/Dr. Umesh Bilagi  Submittted/Under Review 
KEM Hospital Research Centre EC/ Pune/Dr Kalashetti Suhas  Submittted/Under Review 
KFRCEC_Secundrabad_DrPremchand  Approved 
KLE UniversityEC/Belgaum/Dr.Sanjay Porwal  Submittted/Under Review 
Krishna Institute of Medical Sciences EC/ Karad/Dr Aparna Patange  Submittted/Under Review 
Lisie Hospital EC/ Cochin/Dr Jabir Abdulla kutty  Approved 
Lokmanya Tilak Municipal Medical College Institutional EC/ Mumbai/Dr Sudhir Pawar  Submittted/Under Review 
MadrasMedicalMission_Chennai_DrUlhasPandurang  Approved 
Maharashtra Medical Research Society EC/ Pune/Dr Nitin Patki  Approved 
Manipal Hospital EC/Bangalore/ Dr Shamanna Iyengar  Submittted/Under Review 
Max Super Speciality Hospital EC/New Delhi/Dr Naresh Kumar Goyal  Submittted/Under Review 
MaxSuperspecialityHospitalEC_NewDelhi_DrSumeetSethi  Approved 
MedantaEC_Gurgaon_DrChopra  Approved 
MedicitiEC_Hyderabad_DrRRReddy  Approved 
MeditrinaEC_Nagpur_DrHarkut  Approved 
MSRamaiahyMedicalCollege&Hospital_DrVSPrakash  Approved 
Mysore Medical College and Research Institute EC/ Mysore/Dr Ravishankar Airody  Approved 
NarayanaHealthMedicalEC_Bangalore_DrBagirath  Approved 
NarayanaHealthMedicalEC_Bangalore_DrShriharidas  Approved 
Nirmal Hospital Private Ethics Committee_Surat_Dr. Atul Damodar Abhyankar   Submittted/Under Review 
Nirmaya Hospital Ethics Committee_Pune_Dr. Abhijeet Bhaskar Joshi  Submittted/Under Review 
Noble Hospital Pvt. LtdEC/ Pune/Dr Rahul Patil  Approved 
Omega Ethics Committee_Manggalore_Dr. Mukund Kumbla  Submittted/Under Review 
Sanjeevan Hospital EC/ Pune/ Dr Rituparna Shinde  Approved 
Sir Ganga Ram Hospital Ethics Committee_NewDelhi_Dr. Jitendra Pal Singh Sawhney  Submittted/Under Review 
SPMedicalCollegeandAGHospitalsEC_Bikaner  Submittted/Under Review 
SRKallaMemorialEC_Jaipur_Dr.RishabhMathur  Submittted/Under Review 
SRM Medical College Hospital & Research Center  Submittted/Under Review 
St John’s Medical College & Hospital EC/ Bangalore/Dr.Srilakshmi Mandayam Adhyapak  Approved 
Sunshine Hospital EC/ Secunderabad/Dr Sharath Annam  Approved 
Vintage Hospital & Medical Research Centre EC/Panji/Dr Rufino Monteiro  Approved 
Virtuous Institutional Medical Research Ethics/Nagpur/Dr. Mahesh Chandulal Fulwani  Submittted/Under Review 
WestfortHi-Tech Hospital Ltd EC/ Thrissur / Dr Mohanan Padinhare  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Hypercholesterolemia, (1) ICD-10 Condition: E780||Pure hypercholesterolemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Injection through subcutaneous (SC) administration every 2 weeks for approx 280 weeks 
Intervention  SAR236553  75mg/150mg Injection through subcutaneous (SC) administration Every 2 weeks for approx 280 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Recently hospitalized for ACS

For complete list of exclusion criteria, please contact sponsor
 
 
ExclusionCriteria 
Details  Age less than 40 years; ACS event occurring more than 16 weeks prior to randomization visit; LDL-C likely to be < 70 mg/dL (< 1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia

For complete list of exclusion criteria, please contact sponsor
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time from randomization to first occurrence of one of the following clinical events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization   up to 64 months 
 
Secondary Outcome  
Outcome  TimePoints 
Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality  up to 64 months 
Change from baseline in blood lipids and lipoprotein levels  Up to 64 months 
Number of patients with adverse events  Up to 64 months 
 
Target Sample Size   Total Sample Size="18000"
Sample Size from India="1800" 
Final Enrollment numbers achieved (Total)= "18927"
Final Enrollment numbers achieved (India)="521" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/02/2014 
Date of Study Completion (India) 09/12/2017 
Date of First Enrollment (Global)  01/10/2012 
Date of Study Completion (Global) 23/01/2018 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet available 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The primary objective of this study is to compare the effect of SAR236553 with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s). This study will be done in about 50 countries and will enroll about 18000 patients.

 
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