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CTRI Number  CTRI/2011/09/002016 [Registered on: 23/09/2011] Trial Registered Prospectively
Last Modified On: 07/04/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) 
Scientific Title of Study   A Randomized, Double-blind, Placebo-controlled, Event Driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-myocardial Infarction Patients With Elevated hsCRP 
Secondary IDs if Any  
Secondary ID  Identifier 
CACZ885M2301  Protocol Number 
NCT01327846  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Murugananthan K 
Designation  Head - Clinical Development 
Affiliation  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate,
Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India 
Phone  022-24958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query
 
Name  Murugananthan K 
Designation  Head - Clinical Development 
Affiliation  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate,
Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India 
Phone  022-24958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma, A.G. 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India
United States of America  
Sites of Study
Modification(s)  
No of Sites = 72  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A K Awasthi  Ajanta Research Centre  Ajanta Hospital and IVF centre, Kanpur Road, Near Krishna Cinema, Alam Bagh, Lucknow - 226005, U.P.
Lucknow
UTTAR PRADESH 
919415063607
915222465223
drakawasthi@gmail.com 
DrAbraham Ooman  Apollo Hospital  Department of Cardiology,No,654/646, TH Road, Tondiarpet Chennai -600081
Chennai
TAMIL NADU 
914425913333
25915599
aht@apollohospitals.com 
DrSubir Ghosh  Apollo Hospitals International Limited  Plot No.1A, BHAT GIDC Estate, Gandhinagar- 382428, Gujarat, India.
Gandhinagar
GUJARAT 
919825581915
917966701876
drsubirghosh@rediffmail.com 
DRSUNIL THANVI  B & M PATEL CARDIAC CENTRE  SHREE KRISHNA HOSPITAL AND MEDICAL RESEARCH CENTRE, GOKUL NAGAR, KARANSAD
Anand
GUJARAT 
09825012296
269222493
sunilt@charutarhealth.org 
Dr Darshan Banker  Bankers Heart Institute  Old Padra Road, Vadodara - 390015, Gujarat
Vadodara
GUJARAT 
919825029727
0265-2327401
dnb@bankersheart.com 
DrShivkumar Rathnavel  Bhagwan Mahaveer Jain Hospital &Research Centre  10-1-1 AC Guards,Hyderbad-500004,Andhra Pradesh.
Hyderabad
ANDHRA PRADESH 
919842158870
04426561801
drsivakumar2004@yahoo.co.uk 
DrShivakumar Yerra  Bhagwan Mahaveer Jain Hospital& Research Center  10-1-1 AC Guards, Hyderabad- 500004, Andhrapradesh
Hyderabad
ANDHRA PRADESH 
00919000700171
00914023320447
shivakumar.yerra@gmail.com 
DrBharti Goyal  Bharti Clinic  Dr.Bharti Aggarwal,96-B, Rajguru Nagar Ludhiana-141012
Ludhiana
PUNJAB 
919876875444
01614618093
bhartiparshant@yahoo.co.in 
Dr Vikas Bisne  Bisne Hospital Pvt. Ltd  107/1, Farmland,Ramdaspeth, Nagpur - 440 0010,Maharashtra
Nagpur
MAHARASHTRA 
9823018080
917122440070
vikasbisne@gmail.com 
Dr Seesha Srinivasa Raju  Bollineni Superspeciality Hospital  Department of Cardiology, Bollineni Superspeciality Hospital, Dargamitta, Nellore-524003 (A.P.)
Nellore
ANDHRA PRADESH 
09848170806
08612302164
cssraju_66@yahoo.co.in 
Dr Nitin Patki  Cardiac Research, Deenanath Mangeshkar Hospital & Research centre  Near Mhatre Bridge, Erandwane, Pune, 411004
Pune
MAHARASHTRA 
919822041699
912025420104
nitin1patki@gmail.com 
Dr Sunil V Sathe  Cardiac Care & Counselling Centre  4th Floor, Park Plaza, Ketkar Path, Opp. Kamla Nehru Park, off. Bhandarkar Road, Pune, Maharashtra-411004
Pune
MAHARASHTRA 
912025663890
912025663891
svscardcare@gmail.com 
Dr M S Rao  Care Foundation  Care Hospital,Road No 1, Banjara Hills,Hyderabad-500034
Hyderabad
ANDHRA PRADESH 
9848038277
914024608525
maddurysrinivas@hotmail.com 
Dr Bhaskara Rao  CARE HOSPITAL  CARE HOSPITAL, 10-50-11/5, WALTAIR MAIN ROAD, RAM NAGAR, Visakhapatnam - 530002
Visakhapatnam
ANDHRA PRADESH 
919246624766
918916617791
bhaskarstudies@hotmail.com 
Dr Aniket Puri  Chhatrapati Shahuji Maharaj Medical University   Department of Cardiology, Chhatrapati Shahuji Maharaj Medical University, LARI Cardiology Centre, Fmr. King George Medical University, Lucknow - 226003, U.P.
Lucknow
UTTAR PRADESH 
919335811074
915222258552
aniketpuri@hotmail.com 
Dr Prabhakar Shetty  Columbia Asia Referral Hospital  Yeshwanthpur,#26/1, Brigade Gateway, Beside Metro, Malleshwaram West, Bangalore
Bangalore
KARNATAKA 
918030925689
918030925688
pheggunje@gmail.com 
Dr Aziz Khan  Crescent Hospital & Heart Centre  Crescent Hospital & Heart Centre,Near Lokmat square, dhantoli, Nagpur -440 012, Maharashtra
Nagpur
MAHARASHTRA 
919823056551
917122420698
khandraziz@gmail.com 
Dr Gurpreet Singh Wander  Dayananad Medical College and Hospital  Tagore Nagar, Civil Lines, Ludhiana (Punjab) -141001
Ludhiana
PUNJAB 
911612304282
911612304289
drgswander@yahoo.com 
DrRakesh Kumar Aggarwal  Deep Heart Centre  478-L, Model Town, Ludhiana - 141002, Punjab
Ludhiana
PUNJAB 
919814215692
911615023998
aggarwal.rakeshkumar@yahoo.com 
Dr Vikas G Pai   Dr Vikas G Pai Clinical Research Foundation  Abhinav Apt. ,778/ B1 Next to Congress House , Pune -411005. Maharashtra.
Pune
MAHARASHTRA 
919890035437
912025534944
dr.paivikas@gmail.com 
DrHarsh Wardhan  Dr. Ram Manohar Lohia Hospital  Head of Dept. of Cariology, Baba Kharak Singh Marg, New delhi 110001.
New Delhi
DELHI 
919958113366
9123747053
hwardhan@hotmail.com 
DrKrishnaMohan G  Dr. Ramesh Cardiac & Multispeciality Hospital LTD  Ring Road, Near I.T.I College, Vijaywada- 520008, Andhrapradesh.
Krishna
ANDHRA PRADESH 
919848133852

krishnagutlapalli@gmail.com 
Dr Upendra Kaul  Fortis Escorts Heart Institute & Research Center,  Clinical Research, Room No-23, 2nd Floor, Residential Tower, RC Block, Fortis Escorts Heart Institute & Research Center, Okhla Road, New Delhi, India-110025
New Delhi
DELHI 
919811150518
911126825112
ukaul@vsnl.com 
Dr Harinder Bali  Fortis Hospital  Department of Cardiology, Fortis Hospital, Sector - 62, Phase - VIII, Mohali – 160062. Punjab
Hoshiarpur
PUNJAB 
9872735980
01724692221
hkbalipgi@gmail.com 
Dr Rajpal Abhaichand  G. Kuupuswamy Memorial Hospital  Nethaji Road, Papanaickenpalayam, Coimbatore - 641037
Coimbatore
TAMIL NADU 
919443272172
04222243509
drrajpal@yahoo.com 
Dr Suhas Hardas  Hardas Heart Care  5th Floor, Fortune Plaza, Thube Park, Shivaji Nagar, Pune- 411005
Pune
MAHARASHTRA 
919822008910
912041028989
suhas_h@hotmail.com 
DrJay Shah  HCG Medi-Surge Hospital  Nr. Mithakali Six Road, Ellisbridge, Ahmedabad - 380006
Ahmadabad
GUJARAT 
919898209755
917926441401
jayshah08@yahoo.co.in 
Dr Atul Abhyankar  Heart First Cardiac and Vascular Centre,  F-10 Sheron Plaza, Athwalines Road, Parle Point, Surat- 395007
Surat
GUJARAT 
91912613072879
912613072879
atulda@hotmail.com 
DrDevang Desai  Hridayam Heart Care,  Department of cardiology, E-5, Swaminarayan Complex Majuragate, Char Rasta, Ring road, Surat- 395001
Surat
GUJARAT 
09825117900

devang_hridyam@yahoo.co.in 
DrJtotirmoy Pal  IPGMER and SSKM Hospital  SSKM Hospital, 244 A.J.C Bose Road, Kolkata - 700 020, Kolkata - 700020, West Bengal
Kolkata
WEST BENGAL 
919433230319
913322236558
j_pal2004@rediffmail.com 
Dr Nitthiyan Palaniswami  K. Govindaswami Naidu Medical Trust, KG Hospital  15-2-79, 80, G.S. Mada Street No:5, Government Arts College Road, Coimbatore 641 018, Tamil Nadu
Coimbatore
TAMIL NADU 
04222212121
04222211212
kgclinicaltrials@gmail.com 
DrBhavesh Thakkar  Kalcadiya Hospital  B/H Sukhsagar Complex, LB Shastri Marg, opposite Dinesh Chamber, Bhapunagar, Ahmedabad - 380025
Ahmadabad
GUJARAT 
919898022444
917922203031
bthakkarin@yahoo.co.in 
DrTom Devasia  Kasturba Hospital   Madhav Nagar, Post Box No. 7,Manipal - 576 104, Karnataka
Udupi
KARNATAKA 
9448158508
08202571999
tomdevasia@hotmail.com 
Dr Saket Goyal  Kota Heart Institute  10 A- Talwandi, Jhalawar Road, Kota, Rajasthan - 324005
Kota
RAJASTHAN 
9352605286
7442405010
drskhitrial@gmail.com 
Dr Venkobashetty Sirigeri Srinath  Krishna Institute Of Medical Sciences  1-8-31/1, Minister Road, Secunderabad - 500003. AP
Hyderabad
ANDHRA PRADESH 
00919894257706

srinathsirigeri@yahoo.co.in 
Dr Raghav Sarma  Lalitha Superspecialities Hospital Pvt Ltd,  Kothapeta, Guntur- 522001, Andhrapradesh
Guntur
ANDHRA PRADESH 
919440808620
918632332866
drpvr.lssh@gmail.com 
Dr Dhamodaran Kaliyamurthy  LifeLine Multispeciality Hospital  LifeLine Multispeciality Hospital, No 5/639 Rajiv Gandhi Salai (OMR), Perungudi,Chennai 600 096
Chennai
TAMIL NADU 
919840754132
914442803775
drdhamu03@yahoo.com 
Dr Jabir Abdullakutty  Lisie Hospital  Department of Cardiology, P.B. # 3053, Kochi-682018
Ernakulam
KERALA 
919447011773
914842401821
drjabi@yahoo.co.in 
DrSandeep Kumar Gupta  M.V. Hospital & Research Centre  314/30, Mirza Mandi Chowk, Lucknow - 226003, U.P.
Lucknow
UTTAR PRADESH 
919415026054
915224079157
sandeepkumar.gupta@rediffmail.com 
DRVIVEKA KUMAR  MAX SUPER SPECIALITY HOSPITAL  2 PRESS ENCLAVE ROAD SAKET
New Delhi
DELHI 
1126515050
1126565060
viveka.kumar@maxhealcare.com 
DRRAJNEESH KAPOOR  MEDANTA THE MEDICITY  SEC-38,GURGAOAN(HR),
Gurgaon
HARYANA 
09971991740
911244834111
rajneesh.kapoor@medanta.org 
Dr Naveen Reddy  Mediciti Hospitals  5-9-22,Secretariat Road,Hyderabad - 500 063Andhra Pradesh
Hyderabad
ANDHRA PRADESH 
00919848045814
914023299078
prodduturnaveen@yahoo.co.in 
Dr Ramesh Babu  Medwin Hospitals  Medwin Hospitals Raghava Ratna Towers, CHirag Ali Lane, Nampalli, Hyderabad - 500001.
Hyderabad
ANDHRA PRADESH 
91-9177000889
91-40-23204053
rameshbabubyrapaneni@yahoo.co.in 
Dr Ramesh Babu  Medwin Hospitals  Medwin Hospitals Raghava Ratna Towers, CHirag Ali Lane, Nampalli, Hyderabad - 500001.
Hyderabad
ANDHRA PRADESH 
91-9177000889
91-40-23204053
rameshbabubyrapaneni@yahoo.co.in 
Dr Mukund Kumbla  Omega Hospital  Mahaveer Circle, Pupwell Circle, Mangalore- 575002
Bangalore
KARNATAKA 
919845082811
08242430700
drmukund@epsilon.net.in 
Dr N Srinivasa Rao  Osmania General Hospital  Department of General Medicine, Osmania General Hospital, Afzalgunj, Hyderabad-500012
Hyderabad
ANDHRA PRADESH 
919440235092
914024744424
drnanyam@yahoo.com 
Dr Sanjeev Chaudhary  Paras Hospital  Paras Hospital, C-1, Sushant Lok, Phase- I, Sector-43, Gurgaon, Haryana 122002
Gurgaon
HARYANA 
919811093491
91-124-458572
drsanjeevcardio@gmail.com 
Dr M Praveen  Praveen Cardiac Center  #3-25-35 /C, BellapuSobhanadri Street, Kasthuribaipet, Pushpa Hotel Road,Vijayawada
Krishna
ANDHRA PRADESH 
00919848023634
918666662024
drpraveen.pcc@gmail.com 
DrRaghu C  Prime Hospitals  Plot no.4, Besides Blue Fox Hotel, Ameerpet - 500 034,Hyderabad.
Hyderabad
ANDHRA PRADESH 
91-9848155650

drcraghu@hotmail.com 
Dr Jagadesha subramaniam Bhuvaneswaran  PSG Hospitals  Department of Cardiology, Peelamedu, Avinashi Road, Coimbatore- 641004
Coimbatore
TAMIL NADU 
00919843015419
04224397910
drbhucbect@yahoo.co.in 
Dr Gaurav Minocha  Pushpanjali Crosslay Hospital  W 3, Sector-1, Vaishali, N.H. 24, Gaziabad, NCR, U.P.
Ghaziabad
UTTAR PRADESH 
919910922299

gminocha27@yahoo.co.in 
DRNIRAV BHALANI  Rhythm hEART AND LUNG INSTITUTE  LAKULESH PARK SOCIETY, NR.SADHUVASVANI SCHOOL, NEW VIP ROAD,
Vadodara
GUJARAT 
2652460725

rhythmec13@gmail.com 
Dr Pankaj Bohra  RKB Maxima Heart Institute & Research Centre  Dr. Sardar Singh Memorial Hospital, D-78, Ghiya Marg, Bani Park, Jaipur - 302016, Rajasthan
Jaipur
RAJASTHAN 
919829290388
01412282228
bohrapankaj@hotmail.com 
Dr Devendra Kumar Agarwal  S.P. Medical college & A.G. Hospital,  Shivraj Singh/Dr. B.K. Jain, Research Cell, Department of Cardiology, S.P. Medical college & A.G. Hospital, Bikaner - 334003, Rajasthan
Bikaner
RAJASTHAN 
9829217899
01512525451
tippy1234@rediffmail.com 
Dr Anil Jain  SAL Hospital  Opposite Doordarshan Tower, Drive-in-road, Thaltej, Ahemedabad-380054
Ahmadabad
GUJARAT 
919825063284
917940054103
dranilrjain@yahoo.co.in 
Dr Monica Gupta  Samvedna Hospital  B-27/88G, Ravindrapuri, Varanasi, UP-224105, India
Varanasi
UTTAR PRADESH 
05422276890
9415336322
monicag221@gmail.com 
DrAdityaKapoor  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Block - C, Department of cardiology, Raebareli Raod, Lucknow - 226014, U.P.
Lucknow
UTTAR PRADESH 
919839008893
915222668573
akapoor65@gmail.com 
Dr Kamal Sharma  Sanjeevani Superspeciality Hospital  1, Uday Park society, Nr. Sunrise park, Vastrapur, Ahmedabad- 380 051
Ahmadabad
GUJARAT 
919426020154
917926300411
kamalsharma1975@rediffmail.com 
Dr Jashvant Patel  Shri Bachubhai Dahyabhai Mehta Mahavir Heart Institute  Mahavir Health Campus, Athwagate, Ring Road, Surat- 395001
Surat
GUJARAT 
919825129555
912612462119
drjashvant.patel@gmail.com 
DrMahesh Fulwani  Shri Krishna Hrudayalaya & Critical Care Centre  Tikekar Road, Congress Nagar Square, Dhantoli, Nagpur- 440012
Nagpur
MAHARASHTRA 
919823078146
00917122440120
maheshfulwani@yahoo.co.in 
DrDeepak Chauhan  Shri Nidan Hospital  27-28, Vidhut Nagar- A, Ajmer Road Jaipur- 302024
Jaipur
RAJASTHAN 
9829058527
911412356669
drdchauhan22@gmail.com 
DrGursaran Sidhu  Sidhu Hospital Pvt. Ltd,  G.T. Road, Doraha - 141421, Dist. Ludhiana, Punjab
Ludhiana
PUNJAB 
919876177701
911628501346
gursaransidhu@gmail.com 
DrAshwani Mehta  Sir Ganga Ram Hospital  Dharam Vira Heart Center, 5th Floor, Sir Ganga Ram Hospital, New Delhi - 110060
West
DELHI 
09811057384
911142437231
drashwanimehta@gmail.com 
Dr Yugandhar Bachhu  Sri Venkata Sai Hrudayalaya   15-2-79, 80, G.S. Mada Street Tirupathi-517501, Andhra Pradesh
Adilabad
ANDHRA PRADESH 
9848110272
00918772253030
drybachhu@gmail.com 
Dr Durgaprasad Rajasekhar  Sri Venkateswara Institute Of Medical Sciences Department Of Cardiology  Sri Venkateswara Institute Of Medical Sciences Department Of Cardiology, Head of the Department, Tirupati-517 507. Andhra Pradesh
Chittoor
ANDHRA PRADESH 
91-9849221650
91-0877-2288133
drdrsekhar@yahoo.co.in 
Dr K P Shamsuddeen  St. Isabels Hospital  St. Isabels Hospital, 49, Olive Road, Mylapore, Chennai- 600004
Chennai
TAMIL NADU 
919840044287
4424984776
kpshamsuddeen@gmail.com 
Dr Chandrakant Patil  St. John Medical college Hospital,Department fo Cardiology  Department fo Cardiology, 3rd Floor, Silver Jublee Block, St. John Medical college Hospital, Sarjapur Road, John Nagar, Koramangala, Bengaluru - 560034, Karnataka
Bangalore
KARNATAKA 
9845041311
08025630603
drcbpatil@gmail.com 
Dr Shivakumar Reddy  Sumana Hospitals  III Floor, Vivekananada nagar Colony,Hyderabad-500072
Hyderabad
ANDHRA PRADESH 
040-23162899
040-23162899
dr.sivakumarreddy@rediffmail.com 
Dr Anil Krishna  Sunshine Hospitals  Behind Paradise Hotel, Penderghast Road, Opposite Parsi Dharmasala,
Hyderabad
ANDHRA PRADESH 
00919849593231
914027890091
dranilkrishnadm@gmail.com 
Dr Vinod Vijan  Vijan Cardiac & Critical Care Centre  Vijan House, Dr. Vijan Hospital Marg, College Road, Nasik- 422 005
Nashik
MAHARASHTRA 
919822025353
912532577762
vmvijan@gmail.com 
Dr Hasmukh Dobariya  Vraj Heart Care  -203, L.P Doctor House, Below Sanjivani I.C.U., Lal Darwaja Road, Surat-395001
Surat
GUJARAT 
00919824120658
912616554535
vrajheartcare@gmail.com 
DrPrashant Jagtap  Wockhardt Heart Hospital  27, Corporation Colony, North Ambazari Road, Nagpur- 440 033
Nagpur
MAHARASHTRA 
919823078238
917122249911
pmjagtap@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 66  
Name of Committee  Approval Status 
Institutional Ethics comittee, Dr Bali,Fortis Hospital  Approved 
Lalitha Super Specialities Hospital Ethics committee,Lalitha Superspecialities Hospital Pvt Ltd  Approved 
Apollo Hospital Educational and Research Foundation, Dr.Abraham Oomman  Approved 
Bankers Ethics Committee,Bankers Heart Institute,  Approved 
Bio-ethic Forum of Lucknow, Uttar Pradesh  Approved 
Canara Research Ethical Committee,Mangalore,Dr. Mukund Kumbla  Approved 
Central India Medical Research Ethics Committee,,Nagpur,Dr. Mahesh Fulwani   Approved 
Central India Medical Research Ethics Committee,Nagpur,Dr. Prashant Jagtap   Approved 
Central India Medical Research,Nagpur,Dr. Vikas Bisne  Approved 
Citi Cardiac Research Centre Ltd,Vijayawada,Dr. Krishna Mohan  Approved 
CLINICOM,Nellore,Dr. Seesha Srinivasa Raju  Approved 
Convenor Ethics Committee Osmania Medical College  Submittted/Under Review 
Drug trial Ethics Committee, Dayanand Medical College  Approved 
Ethical Review Board,MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE  Approved 
Ethics Commite Chhatrapati Sahuji Maharaj Medical University  Submittted/Under Review 
Ethics commitee ,Life line Multi Speciality Hospital  Approved 
Ethics Committee on Clinical trials,New delhi,Dr. Harsh Wardhan  Submittted/Under Review 
Ethics Committee, Biniwale Clinic,Dr. Hardas  Approved 
Ethics Committee, Biniwale Clinic,Dr. Sunil V. Sathe  Approved 
Ethics Committee, S.P. Medical College & A.G. Hospitals, Bikaner  Approved 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
Ethics Committee-Apollo Hospitals International Limited  Approved 
Global Health Concern Ethics Committee,Nagpur,Dr. Aziz Khan  Approved 
HCG-Medisurge Ethics CommitteeHCG-Medisurge Hospitals  Approved 
Heart First Ethics Committee,Heart First Cardiac and Vascular Centre  Approved 
Human Research Ethics Committee -Dr.Sunil Thanvi  Submittted/Under Review 
Hyderabad Central Ethics Committee,Dr. Shivakumar Reddy,Hyderabad   Submittted/Under Review 
Independent Ethics Committe. Doraha,  Approved 
Independent Ethics Committee Ludhiana,Dr. Rakesh Kumar Aggarwal  Approved 
Independent Ethics Committee,Bharti Clinic, Ludhiana.  Approved 
Instituional Ethics Committee,G.Kuppuswamy Naidu Memorial Hospital,Dr. Rajpal Abhaichand   Approved 
Institute Ethics Committee,CARE HOSPITAL  Approved 
Institutional Ethical Review Board,St. John Medical college Hospital  Approved 
Institutional Ethics Committe for Biomedical Research,BMMRC  Approved 
Institutional Ethics Committee -Dr.Viveka Kumar  Submittted/Under Review 
Institutional Ethics Committee for M.V. Hospital & Research Centre  Approved 
Institutional Ethics Committee KG Hospital-Dr Nitthiyan  Approved 
Institutional Ethics Committee Prime Hospitals.  Approved 
Institutional Ethics Committee, Medwin Hospital,Dr.Ramesh Babu, Nampally  Approved 
Institutional Ethics Committee, Pushpanjali Crosslay Hospital  Approved 
Institutional Ethics Committee, SGPGIMS, Lucknow  Approved 
Institutional Ethics Committee,Columbia Asia Referral Hospital  Approved 
Institutional Ethics Committee,Deenanath Mangeshkar Hospital & Research centre,Dr. Nitin Patki  Submittted/Under Review 
Institutional Ethics Committee-IPGMER and SSKM Hospital   Approved 
Institutional Human Ethics Committee, PSG IMS & R,Dr. Bhuvaneshwaran  Submittted/Under Review 
KIMS Institutional Ethics Committee,Dr. V.S. Srinath  Approved 
Lisie Hospital Institutional Ethics Committee  Approved 
Mahalasa Independent Ethics Committee,Pune,Dr. Vikas Pai.  Approved 
Manipal University Ethics Committee,Kasturba Hospital & Medical College,Manipal  Approved 
Medanta Institutional Ethics committee -Dr.Rajneesh kapoor  Approved 
Mediciti Ethics Committee,Dr. Naveen Chander Reddy,Hyderabad   Approved 
National Ethics Committee,Chennai,Dr. K.P. Shamsuddeen  Submittted/Under Review 
Paras Hospital Ethics Committee-Dr Sanjeev Chaudary  Approved 
Research Independent Ethics committee, Dr.Devand Desai, Surat  Approved 
Research Independent Ethics Committee,surat,Dr. Hasmukh Dobariya  Approved 
Research Independent Ethics Committee,Surat,Dr. Jashvant Patel  Approved 
Rhythm Heart Institute Ethics Committee -Nirav Bhalani  Submittted/Under Review 
SAL hospital and medical Institute Institutional Review Board,SAL Hospital,Ahemedabad  Approved 
Samvedna Hospital Ethics Committee,Samvedna Hospital,Dr. Monica Gupta   Approved 
Sanjivani Hospital Ethics Committee- Sanjivani Super Speaciality Hospital  Approved 
Sujlam Independent Ethics Committee,Ahmedabad,Dr. Bhavesh Thakkar  Approved 
swastic independent ethics committee, jaipur,Dr. Saket Goyal  Approved 
SWASTIC INDEPENDENT ETHICS COMMITTEE,Jaipur,Dr. Deepak Chauhan  Approved 
Swastic Independent Ethics Committee,Jaipur,Dr. Pankaj Bohra  Approved 
The Independent Ethics Committee,New Delhi,Dr. Upendra Kaul  Approved 
Vijan Hospital Ethics Committee,Vijan Cardiac & Critical Care Centre,Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Atherosclerosis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Canakinumab  150 mg of Canakinumab in 1 mL solution will be injected to pateints quarterly(once in 3 Months), Sub cutaneously throughout the duration of trial(4 years and 5 months). 
Intervention  Canakinumab   50 mg of Canakinumabin 0.5 mL solution will be injected to patient quarterly (once in 3 months), sub cutaneously, throughout the duration of the trial (4 years and 5 months). 
Comparator Agent  Placebo  Matching to interventional drug. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Written informed consent
2.Male, or Female of non-child-bearing potential
3.Age greater than or equal to 18 years.
4.Spontaneous MI at least 30 days before randomization.
5.hsCRP greater tahn or equal to 2 mg per Litre
 
 
ExclusionCriteria 
Details  1.Pregnant or nursing (lactating) women
2.Women of child-bearing potential
3.Any of the following concomitant diseases
4.Planned coronary revascularization (PCI or CABG)
5. Major non-cardiac surgical or endoscopic procedure within past 6 months
6. Multi-vessel CABG surgery within the past 3 years
7. Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA].
8. Uncontrolled hypertension
9. Uncontrolled diabetes
10.History or evidence of active tuberculosis (TB) infection
11.Other protocol-defined inclusion/exclusion criteria may apply
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to first occurrence of a major adverse cardiovascular event, which is a composite endpoint consisting of cardiovascular death, non-fatal MI, and stroke.   36 months 
 
Secondary Outcome  
Outcome  TimePoints 
Time to the first occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, stroke, and hospitalization for unstable angina requiring unplanned revascularization  36 Months 
Time to new onset type 2 diabetes among those with pre-diabetes at randomization.  36 Months 
Time to first occurrence of non-fatal MI, stroke, and all-cause mortality composite  36 Months 
Time to all-cause mortality  36 Months 
 
Target Sample Size   Total Sample Size="7302"
Sample Size from India="1000" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/10/2011 
Date of First Enrollment (Global)  15/04/2011 
Estimated Duration of Trial   Years="5"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   No Publication Provided. 
Brief Summary  

Purpose of the study: To test the hypothesis that canakinumab treatment of patients with MI at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events.

FPFV for India:1-9-2011

Enrolment target for India:1000

 
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