CTRI

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CTRI Number

CTRI/2011/08/001941 [Registered on: 05/08/2011] Trial Registered Retrospectively

Last Modified On:

14/12/2011

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

Scientific Title of Study

A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome

Trial Acronym

ATLAS-ACS 2

Secondary IDs if Any

Secondary ID	Identifier
BAY-59-7939/13194	Protocol Number
NCT00809965	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	Dr. Manish Garg
Designation
Affiliation	Country Medical Director India
Address	Bayer Pharmaceuticals Private Limited Kolshet Road Thane MAHARASHTRA 400607 India
Phone	022-25311448
Fax	022-25455080
Email	manish.garg@bayer.com

Details of Contact Person
Public Query

Name	Dr. Manish Garg
Designation
Affiliation
Address	Bayer Pharmaceuticals Private Limited Kolshet Road Thane MAHARASHTRA 400607 India
Phone	022-25311448
Fax	022-25455080
Email	manish.garg@bayer.com

Source of Monetary or Material Support

Bayer Pharmaceuticals Private Limited

Primary Sponsor
Modification(s)

Name	Johnson Johnson Pharmaceutical Research Development LLC
Address	Johnson & Johnson, Global Clinical Operations, Johnson & Johnson Ltd, 9th Flr, Sigma, Hiranandani Estate, Powai, Mumbai, 400076
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NIL

Countries of Recruitment

Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Egypt
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Mexico
Morocco
Netherlands
New Zealand
Philippines
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Serbia
Slovakia
Spain
Sweden
Thailand
Tunisia
Turkey
Ukraine
United Kingdom
United States of America

Sites of Study

No of Sites = 54
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr. Purushotham	A J Hospital & Research Centre	A J Hospital & Research Centre (Dept. of Cardiology, AJIMS, Mangalore),ept. of Emergency & Trauma, AJHRC-575004	08242225533 8242430700 drrpurushotham@yahoo.com
Dr. Manotosh Panja	AMRI Hospital	AMRI Hospital, Director of Cardiovascular Science , Department of Cardiology,AMRI Hospital, P 4 & 5, CITE Scheme, LXXII, Block A Gariahat Road, Beside Dhakuria Bridge-700029 Kolkata WEST BENGAL	09830318106 033-2461-2536 mpanja@vsnl.net
Dr. Suvro Banerjee	Apollo Gleneagles Hospital	Apollo Gleneagles Hospital, 58,Canal Circular Road-700054 Kolkata WEST BENGAL	9830024131 033-23201739 baners@vsnl.net
Dr Abraham Oomman	Apollo Hospital	Apollo Hospital, No. 645/646,T.H. Road, Tondiarpet -600 081 Chennai TAMIL NADU	+91-9841174578 044 - 25911111 aherftondiarpet@gmail.com
Dr Sudhir Naik	Apollo Hospitals	Heart Institute - Cardiology,Jubilee Hills,-500 033 Hyderabad ANDHRA PRADESH	040-23556622 91-40-23543270 drsudhirnaik04@yahoo.co.in
Dr Hasit Joshi	Apollo Hospitals International Ltd.	Apollo Hospitals, 1A,Bhat GIDC Estate-382 428 Ahmadabad GUJARAT	91-11-25861766 91-011-42437230 aherf@apolloahd.com
Dr. Darshan Banker	Bankers Heart Institute	Bankers Heart Institute,Old Padra Road-390015 Vadodara GUJARAT	02652324004 0265-2327401 info@bankersheart.com
Dr. Parvindar Singh	Baroda Heart Institute & Research Centre	Baroda Heart Institute & Research Centre, 44,Haribhakti Colony, Old Padra Road-390007 Vadodara GUJARAT	91-265-2322021 912652351091 parvindar@yahoo.com
Dr. Vikas Bisne	Bisne Heart Clinic & Hospital	Bisne Heart Hospital, 107/1,Farmland Ramdaspeth-440010 Nagpur MAHARASHTRA	0712-2436536 0712-2430313 vikas_bisne@hotmail.com
Dr.Keyur Parikh	CIMS Hospital	CIMS Hospital, Near Shukan Mall,Off Science City Road-380060 Ahmadabad GUJARAT	+91-79-2771 2771-75 91-11-26225733 keyur.parikh@heartcareclinic.org
Dr. Aziz Khan	Crescent Hospital and Heart Centre	Plot no 25, First Lane,Near Lokmat Square, Dhantoli-440012 Nagpur MAHARASHTRA	+91- 9823056551 91-712-2420698 khandraziz@yahoo.com
Dr. Deepak Jeswani	Criticare Hospital	1st Floor, Vasant Sheela Tower,Opp Lokmat Building, Lokmat Square-440012 Nagpur MAHARASHTRA	0712-2440333 0712-2440444 deepakjeswani2@yahoo.co.in
Dr. Shireesh Sathe	Deenanath Mangeshkar Hospital & Research Centre	Deenanath Mangeshkar Hospital & Research Centre,Erandawane-411 004 Pune MAHARASHTRA	(020)66023000 (020)25466584 shireesh.sathe@gmail.com
Dr. Ramesh Babu Pothineni	Dr. Ramesh Cardiac & Multispeciality Hospital Ltd.	Dr. Ramesh Cardiac & Multispeciality Hospital Ltd. Department of Cardiology,Ring Road Near ITI College-520008	08666 2484800 2486094 Dr_rameshbabu.p@yahoo.co.in
Dr.Nishith Chandra	Escorts Heart Institute & Research Center	Escorts Heart Institute & Research Center,Okhla Road-110025 New Delhi DELHI	91-11-25825000 91-11-26825112 drchandra@hotmail.com
Dr. H.K Bali	Fortis Hospital	Fortis Hospital, Sector 62,Phase VIII-390007	0172-5096222 91-172-5096221 hkbalipgi@gmail.com
Dr. Golla Nagendra Prasad	Frontier Lifeline	R-30-C,Ambattur Industrial Estate Road-600101 Chennai TAMIL NADU	91 44 42017575 +91-44-26565150 prasad_golla@yahoo.com
Dr. Vimal Mehta	G.B Pant Hospital	Jawahar Lal Nehru Marg,Delhi Gate-110002 New Delhi DELHI	011-23234242 011-23234242 drvimalmehta@yahoo.co.in
Dr. Navneet Kumar	Hinduja Hospital	Hinduja Hospital, Veer Savarkar Marg,Mahim-400016 Mumbai MAHARASHTRA	09820092961 2449151 dr.navneetkumar@rediffmail.com
Dr. Sheoji Jaiswal	Jeevan Jyoti Hospital & Research Centre	Jeevan Jyoti Institute of Medical Sciences, 162,Bai Ka Bagh, Lowther Road-211003 Allahabad UTTAR PRADESH	91 9415633622 0532-2557119 dr.jaiswal.ct@gmail.com
Dr. Jaskaran Singh Duggal	Jehangir Clinical Development Centre PVT. Ltd	Jehangir Hospital Premises,32, Sassoon Road-411001 Pune MAHARASHTRA	020-26059318 091 261 3072879 tonydugal@yahoo.co.in
Dr. Subramanyam K.	K S. Hegde Charitable Hospital	Medical Sciences Complex,Mangalore-575 018	91 9980837234 08242204016 drsubramanyam@rediffmail.com
Dr. Bhavesh Thakker	Kalcadiya Hospital	Kalcadiya Hospital , B/H Sukhsagar Complex LB Shastri Marg,Opposite Dinesh Chamber Bapunagar-380025	079 22205858 (079)22203442 bthakkarin@yahoo.co.in
Dr. Vijayaraghavan G	Kerala Institute of Medical Sciences	Kerala Institute of Medical Sciences, P.B.No.1,Anayara P.O-695029 Thiruvananthapuram KERALA	0471- 3041320 91-471-2446535 drvijayaraghavan@gmail.com
Dr. Milind Gadkari	King Edward Memorial Hospital Research Centre	Dept of Cardiology, First floor, Echo Dept,DH Building, KEM Hospital, Rasta Peth-411011 Pune MAHARASHTRA	020-66037432 020-66202260 gadkaris@gmail.com
Dr. Chockalingam Kulasekaran	Kovai Medical Centre & Hospital	P.Box #3209,Avanashi Road- 641014 Coimbatore TAMIL NADU	0422-4214020 0422-4214020 kclingam@gmail.com
Dr. Sunil Thanvi	Krishna Heart Institute	Bhanubhai & Madhuben Patel Cardiac Centre,Shree Krishna Hospital & Medical Research Centre-388325	+91-9825012296 +91 2692 222493 sunilt@charutarhealth.org
Dr. Rakesh Kumar Agarwal	Kulwant Heart & Vascular Centre	Kulwant Heart & Vascular Centre, 11-D,Kitchlu Nagar-141001 Ludhiana PUNJAB	91-1612304554 91-161-5047851 Aggarwal.rakeshkumar@yahoo.com
Dr. K. A. Chacko	Lakeshore Hospital & Research Centre Ltd.	Lakeshore Hospital & Research Centre Ltd. NH-47,Byepass, Maradu, Nettoor-682304	91 484 2701032 91 484 2701966 kachacko@eth.net
Dr. Sameer Dani	Lifecare Institute of Medical Science	Department of Cardiology, Sardar Patel Statue Corner,Sardar Patel Stadium Road, Naranpura, Naranpura Vistar-380013 Ahmadabad GUJARAT	079-40204020 079-26405210 danisameer@hotmail.com
Dr. Jabir Abdullakutty	Lisie Hospital	Lisie Hospital,P.B. #3053-682018	91-484-2403877 91-484-2403877 drjabi@yahoo.co.in
Dr. Sandeep Kumar Gupta	M. V Hospital & Research Centre	M. V Hospital & Research Centre, 314/30,Mirza Mandi Chowk-226003 Lucknow UTTAR PRADESH	91-522 2258215 0522 4016051 sandeepkumar.gupta@rediffmail.com
Dr. Nagamalesh Madappa	M.S. Ramaiah Narayana Hrudatyalaya	Consultant Cardiologist, M.S. Ramaiah Narayana Hrudatyalaya,M.S. Ramaiah Memorial Hospital, MSRIT Post, New BEL Road-560054 Bangalore KARNATAKA	080-22183078 080-40528402 nmalesh@yahoo.co.in
Dr. Nitin Patki	Maharashtra Medical Foundation Joshi Hospital	Maharashtra Medical Foundation Joshi Hospital,, 778,Opposite Kamala Nehru Park-411004 Pune MAHARASHTRA	09822041699 25651602 nitin1patki@gmail.com
Dr. Jaydeep Menon	MAR Augustine Golden Jubilee Hospital	MAR Augustine Golden Jubilee Hospital,Mookkannoor (P.O)-683577	0484-2615700 0484-2616869 menon7jc@gmail.com
Dr. Vijay Kumar Chopra	Medanta Heart Institute	Director Heart Failure Program Department of Cardiology,Medanta Heart Institute Medanta- The Medicity Sector-38-122001 Gurgaon HARYANA	9560398900 012448341111 vk.chopra@medanta.org
Dr. Naveen Chander Reddy	Mediciti Hospitals	Medicti Hospitals, 5-9-22,Secretarait Road-64 Hyderabad ANDHRA PRADESH	040 23231111 040 23299078 prodduturnaveen@yahoo.co.in
Dr. Sivakumar Rathnavel	Meenakshi Mission Hospital & Research Centre	Meenakshi Mission Hospital & Research Centre, Lake Area,Melur Road-625107 Madurai TAMIL NADU	0452 2588741 91-452-2586353 drsivakumar2004@yahoo.co.uk
Dr. Vinod Sharma	National heart institute	National Heart Institute,Community Centre, -11 00 65 New Delhi DELHI	91-11-26428372 91-11-26225733 drvs1994@rediffmail.com
Dr. Abhijit Joshi	Nirmaya Hospital	Nirmaya Hospital, Opp. Chinchwad Railway Station,Chinchwad -411019 Pune MAHARASHTRA	020 40717777 020-27441865 abhibhaskar100@rediffmail.com
Dr. Mukund Kumbla	Omega Hospital	Mahaveer Circle (Pump well),,Mangalore-575002	0824-2430000 0824-2432925 mukundkumble@hotmail.com
Dr. P Sampath Kumar	Osmania General Hospital	Department of Cardiology,Near Afzalgunj Bus stop-500012 Hyderabad ANDHRA PRADESH	04023316989 4024736313 cardoGH@gmail.com
Dr Krishnakumar K	PRS Hospital	PRS Hospital,Killipalam-695 002	0471234443 91-471-2345358 krishnasarith@rediffmail.com
Dr. Bhuvaneswaran Jagadesa Subramaniam	PSG Hospitals	Department of Cardiology,Peelamedu-641 004 Coimbatore TAMIL NADU	0422-2570170 0422-4397910 drbhucbe@yahoo.co.in
Dr. P. K. Grant	Ruby Hall Clinic	Ruby Hall Clinic, 40,Sassoon Road-40 Pune MAHARASHTRA	020-26123391 020-26051177 Purvez_grant@hotmail.com
Dr.Kamal Sharma	Sanjivani Super Speciality Hospital	Sanjivani Super Speciality Hospital, 1, Uday Park Society,Near Sunrise park, Vastrapur-380051 Ahmadabad GUJARAT	9426020154 079-26307165 kamalsharma1975@rediffmail.com
Dr. Atul Abyankar	Shree B.D Mehta Mahaveer Heart Institute	F -10 Sheron Plaza, Opp. Ambika Niketan Bus Stop,Next to Athwalines Road, Parle Point-395007 Surat GUJARAT	0261-2254888 0267-2462113 atulda@hotmail.com
Dr. Jitendrapal Singh Sawhney	Sir Ganga Ram Hospital	Sir Ganga Ram Hospital, Department of cardiology,Dharam Vira Heart Center,5th floor , Old Rajinder Nagar-110060 New Delhi DELHI	91-11-25861766 91-011-42437230 jpssawhney@yahoo.com
Dr. Nikhil Parikh	SK Soni Hospital	SK Soni Hospital, Cardiology Sector 5,Vidhyadhar Nagar-302013 Jaipur RAJASTHAN	01412232409 0141 2232412 nikhil1761@yahoo.co.in
Dr. Prabhavathi	Sri Jayadeva Institute of Cardiology	Bannerughatta Road,Jayanagar 9th Block-560069 Bangalore KARNATAKA	080-22977222 080-26534477 prabhavathi_in@yahoo.com
Dr. A.C Rao	SUT Hospital	Sut Hospital, Department of Cardiology, PB No 1052,Shree Uthradom Thirunal Hospital, Pattom-695004 Thiruvananthapuram KERALA	9387802792 0471-2444304 acr_rao@yahoo.co.in
Dr. Vinod Vijan	Vijan Cardiac & Critical Care Centre	Vijan Cardiac & Critical Care Centre, Vijan House,Dr. Vijan Hospital Marg, College Road-422005 Nashik MAHARASHTRA	0253-2572371 0253-2577762 vmvijan@hotmail.com
Dr. Arun Srinivas	Vikram Hospital and Heart Centre	Department of Cardiology,Vikram Hospital and Heart Care No. 46,Vivekananda Road, Yadavagiri-570020 Mysore KARNATAKA	91 9845028387 0821-4241813 arunsrinivas@vhpl.com
Dr. P.P .Mohanan	Westfort Hi-Tech Hospital Ltd	Department of Cardiology,Poonkunnam-680002 Thrissur KERALA	9846076006 04872388854 drppmohanan@gmail.com

Details of Ethics Committee

No of Ethics Committees= 54
Name of Committee	Approval Status
AJ Ethical Committee	Approved
Bankers Ethics Committee	Approved
Baroda Heart Institute Ethics Committee	Approved
Canara Research Ethical Committee	Approved
Central Ethical Committee Nitte University	Approved
Central Ethics Committee, Apollo Hospitals Group, Chennai	Approved
Central Ethics Committee, Apollo Hospitals Group, Gujarat	Approved
Central Ethics Committee, Apollo Hospitals Group, Hyderabad	Approved
Central India Medical Research Ethics Committee, Nagpur	Approved
Central India Medical Research Ethics Committtee, Nagpur	Approved
Ethical Committe Niramaya Hospital Pvt. Ltd.	Approved
Ethical Review Board M.S. Ramaiah Medical College	Approved
Ethical Review Board Meenakshi Mission Hospital and Research Centre	Approved
Ethics Committee Jehangir Clinical Development Centre	Approved
Ethics Committee Lakeshore Hospital and Research Centre	Approved
Ethics Committee Mediciti Hospitals	Approved
Ethics Committee of Maharashtra Medical Research Society	Approved
Ethics Committee of The Heart Care Clinic	Approved
Ethics Committee Osmania Medical College	Approved
Ethics Committee Poona Medical Research Foundation	Approved
Ethics Committee PRS Hospital	Approved
Ethics Committee Sir Ganga Ram Hospital	Approved
Ethics Committee SUT Hospital	Approved
Ethics Committee, LIMSAR, Ahmedabad	Approved
Global Health Concern Ethics Committee	Approved
Heart First Ethics Committee	Approved
Human Research Ethics Committee	Approved
Independent Ethics Committe Aditya	Approved
Independent Ethics Committee Ludhiana	Approved
Institutional Ethics Committee AMRI Hospitals	Approved
Institutional Ethics Committee and Independent Review Board Jeevan Jyoti Hospital and Research Centre	Approved
Institutional Ethics Committee Apollo Gleneagles Hospitals	Approved
Institutional Ethics Committee Citi Cardiac Research Centre Ltd.	Approved
Institutional Ethics Committee Deenanath Mangeshkar Hospital & Research Centre	Approved
Institutional Ethics Committee for MV Hospital and Research Centre	Approved
Institutional Ethics Committee Frontier Lifeline	Approved
Institutional Ethics Committee Lisie Hospital	Approved
Institutional Ethics Committee Maulana Azad Medical College	Approved
Institutional Ethics Committee West Fort Hi-Tech Hospital	Approved
Institutional Ethics Committee, KEMHRC, Pune	Approved
Institutional Human Ethical Committee Kerala Institute of Medical Sciences	Approved
Institutional Review Board MAGJ Hospital	Approved
Institutional Review Board Fortis Hospital	Approved
KMCH Ethics Committee	Approved
Medanta Independent Ethics Committee	Approved
National Health & Education Society Clinical Research & Ethics Committee	Approved
PSG Institute of Medical Sciences & Research Institutional Ethics Committee	Approved
Sanjivani Hospital Ethics Committee	Approved
Scientific Advisory Research and Ethics Committee All India Heart Foundation	Approved
SEAROC Ethics Committee	Approved
Sri Jayadeva Institute Ethics Committee	Approved
The Independent Ethics Committee	Approved
Vijan Hospital Ethics Committee	Approved
Vikram Hospital Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina ,

Intervention / Comparator Agent

Type	Name	Details
Intervention	RIVAROXABAN	One 2.5 mg rivaroxaban tablet twice daily for up to 6 months or One 5 mg rivaroxaban tablet twice daily for up to 6 months
Comparator Agent	Placebo	One placebo tablet twice daily for up to 6 months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Inclusion Criteria: Ages Eligible for Study: 18 Years and older. There is no upper age limit for this study. Genders Eligible for Study: Both Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation :Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

ExclusionCriteria

Details

Exclusion Criteria:

Patient below 18 years of age.

Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding

Need for continued anticoagulant therapy

Significant renal impairment or known significant liver disease

Method of Generating Random Sequence

Method of Concealment

Other

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome

TimePoints

Primary efficacy endpoint is the composite of CV death, MI, or stroke.

6-day screening phase, - treatment phase (consisting of double-blind treatment and follow-up) extending from Day 1 (baseline). - enrollment period estimated to last 27 months, the double-blind treatment phase will last for an additional 6 months, and the follow-up period will last 30 days, making the total study duration approximately 34 months. Study will end when at least 983 primary efficacy endpoints accrue across both strata, and at least 728 primary efficacy endpoints in Stratum 2

Secondary Outcome

Outcome

TimePoints

The composite of all cause death, MI, or stroke. - Net clinical outcome, defined as the composite of CV death, MI, ischemic stroke, or TIMI major bleeding event not associated with CABG surgery - Assessments of the composite of CV death, MI, stroke, or severe recurrent ischemia requiring revascularization. - Assessments of the composite of CV death, MI, stroke, or severe recurrent ischemia leading to hospitalization.

Target Sample Size

Total Sample Size="15527"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

Phase 3

Date of First Enrollment (India)

10/03/2009

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

26/11/2008

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details

Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6.

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

India: 1550 patients screened, 1469 patients randomized, FPI: 10-Mar-2009, First subject randomized: 17-Mar-2009, Last Patient Enroled : 24-Dec-2010, Last Patient Last Visit : 09-Sep-2011