Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With SAR236553 (REGN727)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/02/004387
• Date of registration: 07-02-2014
• Prospective Registration: Yes
• Primary sponsor: Sanofi Synthelabo India Private Limited
• Public title: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With SAR236553 (REGN727)
• Scientific title: 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 - ODYSSEY Outcomes
• Date of first enrolment: 15-02-2014
• Target sample size: 18000
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6439
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

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

Contacts

• Name: Rajiv De
• Affiliation: Sanofi Synthelabo India Limited

• Name: Vaibhav Salvi
• Affiliation: Sanofi Synthelabo India Limited

Key inclusion & exclusion criteria

Inclusion criteria: Recently hospitalized for ACS



For complete list of exclusion criteria, please contact sponsor


Exclusion criteria: 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Hypercholesterolemia Health Condition 2: E780- Pure hypercholesterolemia

Intervention(s)

Intervention1: SAR236553: 75mg/150mg Injection through subcutaneous (SC) administration Every 2 weeks for approx 280 weeks
Control Intervention1: Placebo: Injection through subcutaneous (SC) administration every 2 weeks for approx 280 weeks

Primary Outcome(s)

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 hospitalizationTimepoint: up to 64 months

Secondary Outcome(s)

Change from baseline in blood lipids and lipoprotein levelsTimepoint: Up to 64 months

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 mortalityTimepoint: up to 64 months

Number of patients with adverse eventsTimepoint: Up to 64 months

Secondary ID(s)

EFC11570- Protocol Amend. 06 version02 dated 05-Dec-2013

NCT01663402

Source(s) of Monetary Support

SANOFI-SYNTHELABO (I) Private Limited, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbaiâ?? 400 072, INDIA

Ethics review

Status: Approved
Approval date: 18/01/2013
Contact:

FortisEscortsHospitalEC_Jaipur_DrRajeevGupta

Status: Approved
Approval date: 23/02/2013
Contact:

MadrasMedicalMission_Chennai_DrUlhasPandurang

Status: Approved
Approval date: 28/04/2013
Contact:

Care Hospital Care Convergence Centre EC/ Hyderabad/Dr Surya Prakash

Status: Approved
Approval date: 07/05/2013
Contact:

Lisie Hospital EC/ Cochin/Dr Jabir Abdulla kutty

Status: Approved
Approval date: 15/05/2013
Contact:

Apollo Hospitals InstitutionalEC/Chennai/Dr Abraham Oomman

Status: Approved
Approval date: 23/05/2013
Contact:

Sanjeevan Hospital EC/ Pune/ Dr Rituparna Shinde

Status: Approved
Approval date: 24/05/2013
Contact:

MaxSuperspecialityHospitalEC_NewDelhi_DrSumeetSethi

Status: Approved
Approval date: 05/06/2013
Contact:

WestfortHi-Tech Hospital Ltd EC/ Thrissur / Dr Mohanan Padinhare

Status: Approved
Approval date: 24/06/2013
Contact:

Dr Ramesh Cardiac Multispeciality Hospital Ltd EC/ Vijayawada/Dr Ramesh Babu Pothineni

Status: Approved
Approval date: 26/06/2013
Contact:

KFRCEC_Secundrabad_DrPremchand

Status: Approved
Approval date: 03/07/2013
Contact:

Fortis Hospital EC/Bangalore/Dr.Keshava Ramaiah

Status: Approved
Approval date: 06/07/2013
Contact:

MSRamaiahyMedicalCollege&Hospital_DrVSPrakash

Status: Approved
Approval date: 20/07/2013
Contact:

Noble Hospital Pvt. LtdEC/ Pune/Dr Rahul Patil

Status: Approved
Approval date: 02/08/2013
Contact:

MedantaEC_Gurgaon_DrChopra

Status: Approved
Approval date: 30/08/2013
Contact:

Maharashtra Medical Research Society EC/ Pune/Dr Nitin Patki

Status: Approved
Approval date: 10/10/2013
Contact:

AMC Met EC/ Ahmedabad/Dr Prasant Bhansali

Status: Approved
Approval date: 15/10/2013
Contact:

Indus Hospital EC/ Vishakhapatnam/Dr Sujatha Vipperla

Status: Approved
Approval date: 24/10/2013
Contact:

IPGME&R Institutional EC/ Kolkata/Dr D P Sinha

Status: Approved
Approval date: 30/10/2013
Contact:

Institutional EC for Human Research/ Kolkata/Dr Santanu Guha

Status: Approved
Approval date: 05/11/2013
Contact:

Mysore Medical College and Research Institute EC/ Mysore/Dr Ravishankar Airody

Status: Approved
Approval date: 13/12/2013
Contact:

Vintage Hospital & Medical Research Centre EC/Panji/Dr Rufino Monteiro

Status: Approved
Approval date: 12/02/2014
Contact:

Sunshine Hospital EC/ Secunderabad/Dr Sharath Annam

Status: Approved
Approval date: 28/07/2014
Contact:

InstitutionalECfor Biomedical Research

Status: Approved
Approval date: 06/08/2014
Contact:

MedicitiEC_Hyderabad_DrRRReddy

Status: Approved
Approval date: 20/08/2014
Contact:

St Johnâ??s Medical College & Hospital EC/ Bangalore/Dr.Srilakshmi Mandayam Adhyapak

Status: Approved
Approval date: 06/09/2014
Contact:

ApolloEC_Ludhiana_DrGrewal

Status: Approved
Approval date: 18/09/2014
Contact:

NarayanaHealthMedicalEC_Bangalore_DrBagirath

Status: Approved
Approval date: 18/09/2014
Contact:

NarayanaHealthMedicalEC_Bangalore_DrShriharidas

Status: Approved
Approval date: 26/09/2014
Contact:

MeditrinaEC_Nagpur_DrHarkut

Status: Approved
Approval date: 25/01/2017
Contact:

Institutional Ethics Committee-HM Patel Centre For Medical Care and Education Karamsad-Dr Sunil Karna

Status: Not Approved
Approval date:
Contact:

B.M. Birla Heart Research Centre Institutional Ethics Committee

Status: Not Approved
Approval date:
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BJ Govt Medical College and Sassoon Government Hospital EC/ Pune/Dr Rohidas Borse

Status: Not Approved
Approval date:
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Chopda Medicare & Research Centre Pvt. Ltd., Magnum Heart InstituteEC/Nashik/Dr. Chopada Manojkumar Bhavarilal

Status: Not Approved
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Crescent HospitalEC/Nagpur/Dr. Khan Mohd Aziz

Status: Not Approved
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Datta Meghe Institute of Medical ScienceEC/Wardha/Dr.ajendra Manakshe

Status: Not Approved
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DeenanathMangeshkarHospital & ResearchCentreEC_Pune

Status: Not Approved
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Institutional EC Artemis Health Institute/Gurgaon/Dr.Manjinder Singh Sandhu

Status: Not Approved
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Institutional ECAndhra Hospital/Vijayawada/Dr. Sreemannarayana J

Status: Not Approved
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InstitutionalEC/Fortis Memorial Research Institute/Gurgaon/Dr. Sanjeev Chaudhary

Status: Not Approved
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Jehangir Clinical Development Centre Pvt. LtdEC/Pune/Dr. Priya Palimkar

Status: Not Approved
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K.E.M Hospital & Seth G.S.Medical College/Mumbai/Dr Prafulla Kerkar

Status: Not Approved
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Kamalnayan Bajaj HospitalEC/ Aurangabad/ Dr Ajit Bhagwat

Status: Not Approved
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Karnataka Institute of Medical Sciences/Hubli/Dr. Umesh Bilagi

Status: Not Approved
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KEM Hospital Research Centre EC/ Pune/Dr Kalashetti Suhas

Status: Not Approved
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KLE UniversityEC/Belgaum/Dr.Sanjay Porwal

Status: Not Approved
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Krishna Institute of Medical Sciences EC/ Karad/Dr Aparna Patange

Status: Not Approved
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Lokmanya Tilak Municipal Medical College Institutional EC/ Mumbai/Dr Sudhir Pawar

Status: Not Approved
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Manipal Hospital EC/Bangalore/ Dr Shamanna Iyengar

Status: Not Approved
Approval date:
Contact:

Max Super Speciality Hospital EC/New Delhi/Dr Naresh Kumar Goyal

Status: Not Approved
Approval date:
Contact:

Nirmal Hospital Private Ethics Committee_Surat_Dr. Atul Damodar Abhyankar

Status: Not Approved
Approval date:
Contact:

Nirmaya Hospital Ethics Committee_Pune_Dr. Abhijeet Bhaskar Joshi

Status: Not Approved
Approval date:
Contact:

Omega Ethics Committee_Manggalore_Dr. Mukund Kumbla

Status: Not Approved
Approval date:
Contact:

Sir Ganga Ram Hospital Ethics Committee_NewDelhi_Dr. Jitendra Pal Singh Sawhney

Status: Not Approved
Approval date:
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SPMedicalCollegeandAGHospitalsEC_Bikaner

Status: Not Approved
Approval date:
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SRKallaMemorialEC_Jaipur_Dr.RishabhMathur

Status: Not Approved
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SRM Medical College Hospital & Research Center

Status: Not Approved
Approval date:
Contact:

Virtuous Institutional Medical Research Ethics/Nagpur/Dr. Mahesh Chandulal Fulwani

Results

• Date Completed: 09/12/2017