CTRI

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CTRI Number

CTRI/2010/091/000233 [Registered on: 06/08/2010]

Last Modified On:

13/11/2018

Post Graduate Thesis

Type of Trial

Interventional

Type of Study
Modification(s)

Drug

Study Design

Other

Public Title of Study
Modification(s)

Treatment of Acute Coronary syndrome with Otamixaban (TAO)

Scientific Title of Study
Modification(s)

"Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy"

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
EFC6204	Protocol Number
NCT01076764	ClinicalTrials.gov

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Godhuli Chatterjee
Designation	Medical advisor
Affiliation	Sanofi Synthelabo (India) Ltd
Address	54/A, Sir Mathuradas Vasanji Road Andheri (East), Mumbai MAHARASHTRA 400093 India
Phone	02230707822
Fax	02230707843
Email	godhuli.chatterjee@sanofi.com

Details of Contact Person
Public Query
Modification(s)

Name	Rajiv De
Designation	Team leader
Affiliation	Sanofi Synthelabo India Limited
Address	54/A, Sir Mathuradas Vasanji Road Andheri (East), Mumbai MAHARASHTRA 400093 India
Phone	02230707830
Fax	02230707843
Email	rajiv.de@sanofi.com

Source of Monetary or Material Support
Modification(s)

Sanofi-Synthelabo (India) Limited 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai 400093

Primary Sponsor
Modification(s)

Name	SanofiSynthelabo India Limited
Address	54/A, Sir Mathuradas Vasanji Road, Andheri (East) Mumbai â€“ 400 093 India
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor
Modification(s)

Name	Address
NIL

Countries of Recruitment
Modification(s)

India
Argentina
Australia
Austria
Belarus
Belgium
Brazil
Bulgaria
Canada
Chile
Colombia
Croatia
Czech Republic
Egypt
Estonia
France
Germany
Greece
Hong Kong
Hungary
Indonesia
Israel
Italy
Jordan
Latvia
Lebanon
Lithuania
Malaysia
Mexico
Netherlands
New Zealand
Norway
Panama
Peru
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Serbia
Singapore
Slovakia
South Africa
Spain
Switzerland
Taiwan
Thailand
Tunisia
Turkey
Ukraine
United Kingdom
United States of America
Viet Nam
Montenegro
The former Yugoslav Republic of Macedonia

Sites of Study
Modification(s)

No of Sites = 35
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Anil Dhal	Artemis Hospital, Gurgaon	Room #1919, Sec 51, Gurgaon, 122001 Gurgaon HARYANA	01246767999 info@artemishealthsciences.com
Dr. Mahorkar Keolchandra	Avanti Institute of Cardiology	Abhyankar Road, Dhantoli,,-440012.	+91 0712 2461599 drudaymahukar@gmail.com
Dr Mukhopadhyay Sushan	B.M Birla Heart Research Centre, Kolkata	1/1, National Library Avenue, Kolkata -700027 Kolkata WEST BENGAL	9432754402 sushan.mukhopadhyay@birlaheart.org
Dr Suhas Lele	Bhailal Amin General Hospital	"Bhailal Amin General Hospital Bhailal Amin Marg Gorwa,Vadodara - 390003 Vadodara GUJARAT	9825025807 lelsuhas@yahoo.com
Dr. Sunil Thanvi	Bhanubhai & Madhuben Patel Cardiac Center PS Medical College & Shri Krishna Hospital,	Gokal Nagar Karamsad,-388325	+91 9825012296 +91 2692 222493 ssthanvi@yahoo.com
Dr Chopda Manoj	Chopda Medicare and Research centre, Nashik	Magnum Heart Institute, Plot No. 3/5, Patil lane no. 1, Laxmi Nagar, Near K B H Vidyalay, Canada Corner, Nashik, Maharashtra - 422005 Nashik MAHARASHTRA	9881201613 rush_manoj@yahoo.com
Dr. Aziz Khan	Crescent Hospital & Heart Centre,	near Lokmat Square, ,-440012,	+91 0712 2420698 +91 0712 2420698 khandraziz@yahoo.com
Dr. Shireesh Sathe	Deenanath Mangeshkar Hospital & Research Center.	Dept. of Cardiology, ,Erandwane. -411004 Pune MAHARASHTRA	+919822053216 020 ? 25466584 shireesh.sathe@gmail.com
Dr Ravindra Kulkarni	Deendayal Memorial Hospital	Deendayal Memorial Hospital National Heart Institute 926 F.C., Road, Shivaji Nagar, Pune - 411004 Pune MAHARASHTRA	9422300251 drravindrakulkarni@gmail.com
Dr. Upendra kaul	Escorts Heart Institute & Research Centre,	Okhla Road, -,-110025 New Delhi DELHI	+91 9911150518 +91 11 26825112 ukaul@vsnl.com
Dr. Bali	Fortis Hospital,	Sector-62, Phase VIII,,-160062,	+91 9872735980 0172 5091980 hkbalipgi@gmail.com
Dr V S Prakash	Gokula Metropolis Clinical Research Centre	Gokula Metropolis Clinical Research Centre; M.S.Ramaiah Memorial Hospital,MSRIT Post,New BEL Road Bangalore-560054 Bangalore KARNATAKA	9844033964 drprakashvs@gmail.com
Dr Ajay Pandey	Heritage Hospital Ltd	Dept of Cardiology,Lanka,-221005 Varanasi UTTAR PRADESH	919415202323 915422369996 dr.ajaypandeyheritage@gmail.com
Dr. Brian Pinto	Holy Family Hospital,	St. Andrews Road,,--400050	91-9820054913 91-24930936 brianpinto@iifc.info
Dr. Sheoji Jaiswal	Jeevan Jyoti Hospital & Research Centre,	,162, Bai Ka Bagh, Lowther Road,-211003,	"+91 9415366322 +91 532 2417225 dr.jaiswal.ct@gmail.com
DrShailender Singh	Kamineni Hospital, Hyderabad	#4-1-1227,King Koti, Hyderabad-500 001,Andhra Pradesh Hyderabad ANDHRA PRADESH	040-40074019 shailendersingh.30@gmail.com
Dr. Prafulla Kerkar	King Edward VII Memorial Hospital,	Dept. Of Cardiology,,E. Borges Road, Parel-400025 Mumbai MAHARASHTRA	91-22-24116732 91-22-4107636/7006 prafullakerkar@rediffmail.com
Dr. Rajendra Premchand	Krishna Institute of Medical Sciences	1-8-31/1, minister Road,,-500003	9848029443 040-27845555 kumarpre@hotmail.com
Dr. Sameer Dani	Life Care Institute of Medical Sciences & Research,	Sardar Patel Statue Corner, ,Stadium Road,-380004,	+91 9825038855 +91 79 40204303 danisameer@hotmail.com
Dr Mathew Rony	Lisie Hospital, Cochin	P.B # 3053,Kochi -682018, Kerala Ernakulam KERALA	04842401821 drronymathew@yahoo.com
Dr Naveen Chander Reddy	Mediciti Hospitals	5-9-22, Secretariat Road, Hyderabad - 500083. Andhra Pradesh Hyderabad ANDHRA PRADESH	040232990078 prodduturunaveen@yahoo.co.in
Dr Rathnavel Sivakumar	Meenakshi Mission Hospital and research centre, Madurai	Lake area, Melur Road,Madurai-625107,Tamil Nadu Madurai TAMIL NADU	045225887411 drsivakumar2004@yahoo.co.uk
Dr Gautam Paladugu	Narayana Hospital, Hyderabad	Malla Reddy Hospital. #1-1-216, Suraram X Road, Jedimentla, Hyderabad - 500055 Hyderabad ANDHRA PRADESH	9052244559 drgautamps@gmail.com
Dr. Vinod Sharma	National Heart Institute,	49-50,,East of Kailash,-65 New Delhi DELHI	+91 011 46606600 +91 011 26225733 drvs1994@rediffmail.com
Dr. Mukand Kumbla	Omega Hospital,	Mahaveer Circle,,Kankanady, -57500	9845082811 91-824-2430700 doctormukund@heartcarehealth.com
Dr. Sanjeev Chaudary	Paras Hospital,	C-I Block,,-122002	+91 124 4585572 +91 124 4585555 sanjeevchau@yahoo.co.in
Dr Kahale Pravin	Platinum Hospital, Mumbai	Color scape Shopping mall, G- 103, D D Upadhyay Marg, Mulund Checknaka. Mulund West, Maharashtra, 411004 Mumbai MAHARASHTRA	9370955077 drpravinkahale@yahoo.com
Dr Praveen Maddirala	Praveen Cardiac Centre, Vijaywada	# 33-25-35/C,No.5 Bus Route,Bellapu Sobhanadri Street, Pushpa Hotel Road, Kasturibaipet,Vijayawada-520010	08662444414 drpraveen.pcc@gmail.com
Dr. Tejas Patel	SAL Hospital	Opp. Doordarshan,,Drive in Road-380054 Ahmadabad GUJARAT	+91-79-26466161 +91 79 26407711 drtpatel@yahoo.com
Dr Fulwani Mahesh	Shri Krishna Hrudayalaya, Nagpur	Tikkekar Road,Congress Nagar, Dhantoli, Nagpur 440012 Nagpur MAHARASHTRA	7122444434 maheshfulwani@yahoo.co.in
Dr. J.P.S. Sawhney	Sir Ganga Ram Hospital,	Dept of Cardiology,,Dharmavera Health Centre,5th Floor-110060	+91 9810059773 +91 11 42437231 jpssawhney@yahoo.com
Dr. Nikhil Parekh	SONI Hospital	"Sector 5, Vidyadhar Nagar,,Main Sikar Road, -302004. Jaipur RAJASTHAN	+91 9829054944 1412232433 nikhil1761@yahoo.co.in
Dr. Keyur Parikh	Sterling Hospital,	Sterling Hospital Road,,Memnagar,-380052 Ahmadabad GUJARAT	+91 79 4001 1814 +91 79 4001814 keyur.parikh@indyamail.net
Dr Srinivas Arun	Vikram Hospital Pvt ltd, Mysore	# 46,Vivekananda Road,Yadavagiri, Mysore- 570020, Karnataka Mysore KARNATAKA	08214242424 cardiology@vhpl.com
Dr Gadkar Narayan	Zynova Heart Hospital, Mumbai	Trimurti Arcade, Near Sarvodaya Hospital, L.B.S Marg, Ghatkopar ( West), Mumbai -400086 Mumbai MAHARASHTRA	02225153337 nggadkar@yahoo.co.in

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 35
Name of Committee	Approval Status
Artemis IRB/Gurgaon/Anil Dhall	Approved
Authentic Independent EC/Mumbai/Narayan Gadkar	Approved
Authentic Independent Ethics Committee/Mumbai/Pravin Kahale	Approved
BhailalAminEC_Vadodara_DrSuhasLele	Approved
BMBirla Hospital and Research Centre Ethics Committee/Kolkata/Sushan Mukhopadhyay	Approved
Canara Research Ethical Committee/Mangalore/Mukund Kumbla	Submittted/Under Review
Central india medical research ethic committee/nagpur/MaheshFulwani	Approved
EC of Life Care Institute of Medical Sciences & Research/Ahmedabad/Sameer Dani	Submittted/Under Review
ECRHS/Mumbai/Prafulla Kerkar	Submittted/Under Review
Ethical Committee/New Delhi/ J P S Sawhney	Submittted/Under Review
Ethical Review Board Meenakshi Mission Hospital & Research Centre/Madurai/SivakumarRathnavel	Approved
Ethics Committee of Avanti Institute of Cardiology Private Limited/Nagpur/Uday Mahorkar	Submittted/Under Review
Ethics Committee of Paras Hospital/Gurgaon/Sanjeev Chaudhary	Submittted/Under Review
Global Health Concern Ethics Committee/Nagpur/Aziz Khan	Submittted/Under Review
Heritage Hospital Ethics Committee/Varanasi/Ajay Pandey	Submittted/Under Review
Human Research Ethics Committee/Anand/Sunil Thanvi	Submittted/Under Review
IEC and IRB Jeevan Jyoti Hospital and Research Centre/Allahabad/Sheoji Jaiswal	Submittted/Under Review
IEC Kamineni Hospitals/Hyderabad/ShailenderSingh	Approved
IEC Lisie Hospital/Kochin/RonyMathew	Approved
IEC, Deenanath Mangeshkar Hospital and Research Centre/Pune/Shireesh Sathe	Submittted/Under Review
Institutional EC/CARE/Ahmedabad/Keyur Parekh	Submittted/Under Review
Institutional EC/Mumbai/Brian Pinto	Submittted/Under Review
Institutional Ethics Committee, Praveen Cardiac Centre/Vijaywada/Pravin Maddiralla	Approved
Institutional Ethics Committee/Fortis Hospital/Mohali/H K Bali	Submittted/Under Review
KIMS Institutional Ethics Committee/Secunderabad/Rajendra Premchand	Submittted/Under Review
Magnacare ethics committee/Nashik/Manoj Chopra	Approved
Mediciti Ethics Committee/Hyderabad/N C Reddy	Approved
NHMRI EC/Hyderabad/P S Gautam	Approved
PantaMedEC_Pune_DrRavindraKulkarni_22Nov2011	Approved
RamaiahMedicalCollegeERB_Bangalore_DrVSPrakash	Approved
SAL Institutional EC/Ahmedabad/Tejas Patel	Submittted/Under Review
SEAROC EC/Jaipur/Nikhil Parikh	Approved
SPECT IRB/New Delhi/Vinod Sharma	Submittted/Under Review
The Independent Ethics Committee, Escorts Heart Institute & Research Centre/New Delhi/Upendra Kaul	Submittted/Under Review
Vikram Hospital Ethics Committee/Mysore/Arun Srinivas	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	"Unstable angina/Non ST segment Elevation Myocardial infarction" , (1) ICD-10 Condition: I222\|\|Subsequent non-ST elevation (NSTEMI) myocardial infarction,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Comparator Agent	"UFH: 60 IU/Kg as IV bolus	(max 4000 IU) followed by an IV infusion
Intervention	otamixaban	Route of administration: Intravenous: Continuous infusion. Bolus of 0.080 mg/Kg followed by an IV infusion of 0.100 mg/Kg/hr or IV infusion of 0.140 mg/Kg/hr.

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	"Inclusion Criteria: Patient with non STE-segment elevation Acute Coronary Syndrome with the following symptoms: Ischemic symptoms (chest pain or equivalent) at rest ≥10 minutes within 24 hours of randomization AND One of the two following criteria: A. New ST-segment depression ≥0.1 mV (≥1 mm), or transient (<30 minutes) STsegment elevation ≥0.1 mV (≥1 mm) in at least 2 contiguous leads on the ECG, OR B. Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal AND Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified) AND Informed consent obtained in writing Exclusion Criteria: 1. Exclusion criteria related to study methodology A. General 1. High likelihood of being unavailable for the Day 180 follow up 2. Age <18 years old (or country?s legal age of majority) 3. Pregnancy, as evidenced by a positive urine pregnancy test performed prior to randomization (applicable only to women of childbearing potential, ie, women who are pre-menopausal or <2 years post-menopausal) 4. Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization, or planned use of investigational agents or devices during the study duration 5. Breastfeeding B. Cardiovascular 6. Revascularization procedure already performed for the qualifying event. 7. Acute ST-segment elevation MI C. Related to prior or concomitant treatments 8. Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization. 9. Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing 10. Patients who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling 2. Exclusion criteria related to the active comparator and/or mandatory background therapies A. Related to eptifibatide 11. Patient who cannot be treated with eptifibatide according to the national labeling (when available). In countries where eptifibatide is not approved the reference label to be considered will be either the European labeling or the US labeling (see Appendix H and Appendix I). B. Related to unfractionated heparin 12. Patient who cannot be treated with unfractionated heparin according to the national labeling C. Related to otamixaban 13. Allergy to otamixaban "

ExclusionCriteria

Details

"Exclusion criteria related to study methodology Any major orthopedic surgery in the 3 months prior to study start Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome Patients at high risk of bleeding Known allergy to heparin - or enoxaparin Any contra-indications to the performance of venography "

Method of Generating Random Sequence
Modification(s)

Other

Method of Concealment
Modification(s)

Other

Blinding/Masking
Modification(s)

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome
Modification(s)

Outcome	TimePoints
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction	from randomization (day 1) to day 7

Secondary Outcome
Modification(s)

Outcome

TimePoints

"1)Triple efficacy composite of all-cause death, new myocardial infarction and any stroke from randomization (Day 1) to Day 7
2)Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction from randomization (Day 1 to Day 30)
3)Adjudicated all-cause Death from randomization (Day 1) to Day 30
4)Procedural thrombotic complications during the index PCI."

"1) For the 1st secondary outcome, the time point is from randomization (Day 1) to Day 7
2)For the 2nd secondary outcome, the time point is fromDay 1 to Day 30
3) For the 3rd secondary outcome, the time point is from randomization (Day 1) to Day 30
4) For the 4th secondary outcome, the time point is during the index PCI."

Target Sample Size
Modification(s)

Total Sample Size="10930"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial
Modification(s)

Phase 3

Date of First Enrollment (India)
Modification(s)

01/04/2010

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

01/05/2010

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial
Modification(s)

Years="2"
Months="2"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

Not yet available

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)

Trial will be conducted in 52 countries all over the world.

Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study.

The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.