Treatment of Acute Coronary syndrome with Otamixaban (TAO)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2010/091/000233
• Date of registration: 06-08-2010
• Prospective Registration: No
• Primary sponsor: SanofiSynthelabo India Limited
• Public title: Treatment of Acute Coronary syndrome with Otamixaban (TAO)
• Scientific title: "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"
• Date of first enrolment: 01-04-2010
• Target sample size: 10930
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1443
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Rajiv De
• Affiliation: Sanofi Synthelabo (India) Ltd

• Name: Dr Godhuli Chatterjee
• Affiliation: Sanofi Synthelabo (India) Ltd

Key inclusion & exclusion criteria

Inclusion criteria: "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 "


Exclusion criteria: "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
"


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- "Unstable angina/Non ST segment Elevation Myocardial infarction" Health Condition 2: I222- Subsequent non-ST elevation (NSTEMI) myocardial infarction

Intervention(s)

Intervention1: 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.
Control Intervention1: "UFH: 60 IU/Kg as IV bolus: (max 4000 IU) followed by an IV infusion

Primary Outcome(s)

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

Secondary Outcome(s)

"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."

Timepoint: "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."

Secondary ID(s)

EFC6204

NCT01076764

Source(s) of Monetary Support

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

Ethics review

Status: Approved
Approval date: 15/03/2010
Contact:

RamaiahMedicalCollegeERB_Bangalore_DrVSPrakash

Status: Approved
Approval date: 17/06/2010
Contact:

Artemis IRB/Gurgaon/Anil Dhall

Status: Approved
Approval date: 13/07/2010
Contact:

SEAROC EC/Jaipur/Nikhil Parikh

Status: Approved
Approval date: 29/01/2011
Contact:

Central india medical research ethic committee/nagpur/MaheshFulwani

Status: Approved
Approval date: 15/02/2011
Contact:

Authentic Independent EC/Mumbai/Narayan Gadkar

Status: Approved
Approval date: 15/02/2011
Contact:

Authentic Independent Ethics Committee/Mumbai/Pravin Kahale

Status: Approved
Approval date: 18/03/2011
Contact:

Magnacare ethics committee/Nashik/Manoj Chopra

Status: Approved
Approval date: 26/03/2011
Contact:

BMBirla Hospital and Research Centre Ethics Committee/Kolkata/Sushan Mukhopadhyay

Status: Approved
Approval date: 21/04/2011
Contact:

BhailalAminEC_Vadodara_DrSuhasLele

Status: Approved
Approval date: 26/04/2011
Contact:

IEC Lisie Hospital/Kochin/RonyMathew

Status: Approved
Approval date: 28/05/2011
Contact:

Ethical Review Board Meenakshi Mission Hospital & Research Centre/Madurai/SivakumarRathnavel

Status: Approved
Approval date: 08/07/2011
Contact:

Mediciti Ethics Committee/Hyderabad/N C Reddy

Status: Approved
Approval date: 22/11/2011
Contact:

PantaMedEC_Pune_DrRavindraKulkarni_22Nov2011

Status: Approved
Approval date: 07/12/2011
Contact:

Institutional Ethics Committee, Praveen Cardiac Centre/Vijaywada/Pravin Maddiralla

Status: Approved
Approval date: 16/04/2012
Contact:

NHMRI EC/Hyderabad/P S Gautam

Status: Approved
Approval date: 16/07/2012
Contact:

IEC Kamineni Hospitals/Hyderabad/ShailenderSingh

Status: Approved
Approval date: 24/07/2012
Contact:

Vikram Hospital Ethics Committee/Mysore/Arun Srinivas

Status: Not Approved
Approval date:
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Canara Research Ethical Committee/Mangalore/Mukund Kumbla

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EC of Life Care Institute of Medical Sciences & Research/Ahmedabad/Sameer Dani

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ECRHS/Mumbai/Prafulla Kerkar

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Ethical Committee/New Delhi/ J P S Sawhney

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Ethics Committee of Avanti Institute of Cardiology Private Limited/Nagpur/Uday Mahorkar

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Ethics Committee of Paras Hospital/Gurgaon/Sanjeev Chaudhary

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Global Health Concern Ethics Committee/Nagpur/Aziz Khan

Status: Not Approved
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Heritage Hospital Ethics Committee/Varanasi/Ajay Pandey

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Human Research Ethics Committee/Anand/Sunil Thanvi

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IEC and IRB Jeevan Jyoti Hospital and Research Centre/Allahabad/Sheoji Jaiswal

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IEC, Deenanath Mangeshkar Hospital and Research Centre/Pune/Shireesh Sathe

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Institutional EC/CARE/Ahmedabad/Keyur Parekh

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Institutional EC/Mumbai/Brian Pinto

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Institutional Ethics Committee/Fortis Hospital/Mohali/H K Bali

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KIMS Institutional Ethics Committee/Secunderabad/Rajendra Premchand

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SAL Institutional EC/Ahmedabad/Tejas Patel

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SPECT IRB/New Delhi/Vinod Sharma

Status: Not Approved
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The Independent Ethics Committee, Escorts Heart Institute & Research Centre/New Delhi/Upendra Kaul