Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With SAR236553 (REGN727) (ODYSSEY Outcomes)
This study is currently recruiting participants.
Verified May 2013 by Sanofi
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01663402
First received: August 8, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
Primary Objective:
To compare the effect of SAR236553 (REGN727) with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.
Secondary Objectives:
To evaluate the effect of SAR236553 (REGN727) on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality).
To evaluate the safety and tolerability of SAR236553 (REGN727). To evaluate the effect of SAR236553 (REGN727) on lipid parameters.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: SAR236553 (REGN727) Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 hospitalization [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 mortality [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
- Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
- Number of patients with adverse events [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18000 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SAR236553 (REGN727)
Injection through subcutaneous (SC) administration - Type: Experimental
|
Drug: SAR236553 (REGN727)
SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) Pharmaceutical form:solution for injection Route of administration: subcutaneous |
|
Placebo
Injection through subcutaneous (SC) administration - Type: Placebo Comparator
|
Other: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
|
Detailed Description:
The maximum study duration will be 70 months, including up to a 4-month run-in period, 64 months randomized treatment period, and 2-month follow-up period.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Recently hospitalized for ACS.
Exclusion criteria:
- Age < 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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663402
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Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
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| United States, Alabama | |
| Investigational Site Number 840148 | Recruiting |
| Auburn, Alabama, United States | |
| Investigational Site Number 840060 | Recruiting |
| Birmingham, Alabama, United States | |
| Investigational Site Number 840117 | Recruiting |
| Huntsville, Alabama, United States, 35801 | |
| Investigational Site Number 840121 | Recruiting |
| Mobile, Alabama, United States | |
| United States, California | |
| Investigational Site Number 840139 | Recruiting |
| Banning, California, United States | |
| Investigational Site Number 840164 | Recruiting |
| Fresno, California, United States | |
| Investigational Site Number 840076 | Recruiting |
| Fullerton, California, United States, 92835 | |
| Investigational Site Number 840073 | Recruiting |
| Huntington Beach, California, United States, 92648 | |
| Investigational Site Number 840150 | Recruiting |
| Lancaster, California, United States, 93534 | |
| Investigational Site Number 840019 | Recruiting |
| Mission Viejo, California, United States, 92691 | |
| Investigational Site Number 840124 | Recruiting |
| Northridge, California, United States, 91325 | |
| Investigational Site Number 840071 | Recruiting |
| Santa Ana, California, United States, 92704 | |
| United States, Colorado | |
| Investigational Site Number 840096 | Recruiting |
| Aurora, Colorado, United States, 80012 | |
| Investigational Site Number 840037 | Recruiting |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Connecticut | |
| Investigational Site Number 840122 | Recruiting |
| Bridgeport, Connecticut, United States, 06606 | |
| United States, Florida | |
| Investigational Site Number 840066 | Recruiting |
| Clearwater, Florida, United States, 33756 | |
| Investigational Site Number 840051 | Recruiting |
| Daytona Beach, Florida, United States, 32117 | |
| Investigational Site Number 840042 | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Investigational Site Number 840206 | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Investigational Site Number 840002 | Recruiting |
| Jupiter, Florida, United States, 33458 | |
| Investigational Site Number 840054 | Recruiting |
| Panama City, Florida, United States, 32401 | |
| Investigational Site Number 840132 | Recruiting |
| Safety Harbor, Florida, United States, 34695 | |
| Investigational Site Number 840061 | Recruiting |
| Safety Harbor, Florida, United States | |
| Investigational Site Number 840247 | Recruiting |
| Sarasota, Florida, United States, 34239 | |
| Investigational Site Number 840213 | Recruiting |
| Trinity, Florida, United States, 34655 | |
| Investigational Site Number 840165 | Recruiting |
| Wellington, Florida, United States, 33449 | |
| United States, Georgia | |
| Investigational Site Number 840075 | Recruiting |
| Atlanta, Georgia, United States | |
| Investigational Site Number 840048 | Recruiting |
| Covington, Georgia, United States, 30014 | |
| Investigational Site Number 840065 | Recruiting |
| Cumming, Georgia, United States, 30041 | |
| Investigational Site Number 840114 | Recruiting |
| Tucker, Georgia, United States, 30084 | |
| United States, Idaho | |
| Investigational Site Number 840211 | Recruiting |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Investigational Site Number 840081 | Recruiting |
| Rock Island, Illinois, United States, 61201 | |
| Investigational Site Number 840111 | Recruiting |
| Winfield, Illinois, United States | |
| United States, Indiana | |
| Investigational Site Number 840036 | Recruiting |
| Hammond, Indiana, United States, 46320 | |
| Investigational Site Number 840026 | Recruiting |
| Indianapolis, Indiana, United States | |
| Investigational Site Number 840102 | Recruiting |
| Muncie, Indiana, United States, 47303-3400 | |
| Investigational Site Number 840145 | Recruiting |
| South Bend, Indiana, United States, 46601-1075 | |
| United States, Iowa | |
| Investigational Site Number 840154 | Recruiting |
| Ames, Iowa, United States, 50010 | |
| United States, Kansas | |
| Investigational Site Number 840140 | Recruiting |
| Overland, Kansas, United States, 66209 | |
| United States, Kentucky | |
| Investigational Site Number 840030 | Recruiting |
| Lexington, Kentucky, United States | |
| United States, Maine | |
| Investigational Site Number 840142 | Recruiting |
| Auburn, Maine, United States, 04210 | |
| Investigational Site Number 840097 | Recruiting |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Investigational Site Number 840072 | Recruiting |
| Beltsville, Maryland, United States | |
| United States, Michigan | |
| Investigational Site Number 840093 | Recruiting |
| Kalamazoo, Michigan, United States | |
| Investigational Site Number 840011 | Recruiting |
| Kalamazoo, Michigan, United States, 49048 | |
| Investigational Site Number 840035 | Recruiting |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, Minnesota | |
| Investigational Site Number 840181 | Recruiting |
| Saint Paul, Minnesota, United States, 55102 | |
| Investigational Site Number 840094 | Recruiting |
| St. Cloud, Minnesota, United States, 56303 | |
| United States, Missouri | |
| Investigational Site Number 840046 | Recruiting |
| Columbia, Missouri, United States, 65201 | |
| Investigational Site Number 840125 | Recruiting |
| St Louis, Missouri, United States, 63141 | |
| Investigational Site Number 840175 | Recruiting |
| St. Louis, Missouri, United States, 63131 | |
| Investigational Site Number 840227 | Recruiting |
| Washington, Missouri, United States | |
| United States, Montana | |
| Investigational Site Number 840032 | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| United States, Nebraska | |
| Investigational Site Number 840033 | Recruiting |
| Grand Island, Nebraska, United States, 68803 | |
| Investigational Site Number 840021 | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| Investigational Site Number 840015 | Recruiting |
| Omaha, Nebraska, United States, 68122 | |
| United States, New Hampshire | |
| Investigational Site Number 840105 | Recruiting |
| Hudson, New Hampshire, United States | |
| Investigational Site Number 840062 | Recruiting |
| Nashua, New Hampshire, United States, 03060 | |
| United States, New Jersey | |
| Investigational Site Number 840173 | Recruiting |
| Bridgewater, New Jersey, United States | |
| Investigational Site Number 840083 | Recruiting |
| Westwood, New Jersey, United States | |
| United States, New York | |
| Investigational Site Number 840017 | Recruiting |
| Poughkeepsie, New York, United States, 12601 | |
| United States, North Carolina | |
| Investigational Site Number 840070 | Recruiting |
| Elizabeth City, North Carolina, United States, 27909 | |
| Investigational Site Number 840088 | Recruiting |
| Statesville, North Carolina, United States, 28627 | |
| Investigational Site Number 840052 | Recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| Investigational Site Number 840131 | Recruiting |
| Cincinnati, Ohio, United States | |
| Investigational Site Number 840045 | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Investigational Site Number 840113 | Recruiting |
| Lorain, Ohio, United States, 44053 | |
| Investigational Site Number 840123 | Recruiting |
| Westlake, Ohio, United States | |
| United States, Oklahoma | |
| Investigational Site Number 840018 | Recruiting |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| Investigational Site Number 840104 | Recruiting |
| Beaver, Pennsylvania, United States, 15009 | |
| Investigational Site Number 840020 | Recruiting |
| Doylestown, Pennsylvania, United States, 18901 | |
| Investigational Site Number 840016 | Recruiting |
| Erie, Pennsylvania, United States | |
| Investigational Site Number 840156 | Recruiting |
| Philadelphia, Pennsylvania, United States, 19151 | |
| Investigational Site Number 840069 | Recruiting |
| Scranton, Pennsylvania, United States, 18503 | |
| United States, Rhode Island | |
| Investigational Site Number 840129 | Recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, South Carolina | |
| Investigational Site Number 840190 | Recruiting |
| Greenwood, South Carolina, United States | |
| United States, South Dakota | |
| Investigational Site Number 840008 | Recruiting |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Investigational Site Number 840126 | Recruiting |
| Knoxville, Tennessee, United States | |
| Investigational Site Number 840195 | Recruiting |
| Oak Ridge, Tennessee, United States, 37830 | |
| United States, Texas | |
| Investigational Site Number 840135 | Recruiting |
| Austin, Texas, United States, 78756 | |
| Investigational Site Number 840152 | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Investigational Site Number 840027 | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Investigational Site Number 840158 | Recruiting |
| Tyler, Texas, United States, 75701 | |
| United States, Virginia | |
| Investigational Site Number 840010 | Recruiting |
| Lynchburg, Virginia, United States, 24501 | |
| Investigational Site Number 840225 | Recruiting |
| Manassas, Virginia, United States, 20109 | |
| United States, Washington | |
| Investigational Site Number 840025 | Recruiting |
| Bellevue, Washington, United States, 98004 | |
| United States, Wisconsin | |
| Investigational Site Number 840059 | Recruiting |
| Green Bay, Wisconsin, United States | |
| Investigational Site Number 840177 | Recruiting |
| Lacrosse, Wisconsin, United States, 54601 | |
| Australia | |
| Investigational Site Number 036015 | Recruiting |
| Bruce, Australia, 2617 | |
| Investigational Site Number 036005 | Recruiting |
| Chermside, Australia, 4032 | |
| Investigational Site Number 036011 | Recruiting |
| Coffs Harbour, Australia, 2450 | |
| Investigational Site Number 036012 | Recruiting |
| Mildura, Australia, 3500 | |
| Investigational Site Number 036013 | Recruiting |
| New Lambton Heights, Australia | |
| Investigational Site Number 036001 | Recruiting |
| Windsor, Australia, 3181 | |
| Belgium | |
| Investigational Site Number 056002 | Recruiting |
| Antwerpen, Belgium, 2020 | |
| Investigational Site Number 056014 | Recruiting |
| Brasschaat, Belgium, 2930 | |
| Investigational Site Number 056023 | Recruiting |
| Liège, Belgium, 4000 | |
| Investigational Site Number 056019 | Recruiting |
| Tienen, Belgium, 3300 | |
| Bulgaria | |
| Investigational Site Number 100007 | Recruiting |
| Sofia, Bulgaria, 1202 | |
| Canada | |
| Investigational Site Number 124004 | Recruiting |
| Moncton, Canada, E1C 4B7 | |
| Denmark | |
| Investigational Site Number 208012 | Recruiting |
| Aalborg, Denmark, 9000 | |
| Investigational Site Number 208011 | Recruiting |
| Aarhus, Denmark, 8200 | |
| Investigational Site Number 208002 | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Investigational Site Number 208003 | Recruiting |
| Glostrup, Denmark, 2600 | |
| Investigational Site Number 208007 | Recruiting |
| Hellerup, Denmark, 2900 | |
| Investigational Site Number 208006 | Recruiting |
| Herning, Denmark, 7400 | |
| Investigational Site Number 208004 | Recruiting |
| Køge, Denmark, 4600 | |
| Investigational Site Number 208009 | Recruiting |
| Odense C, Denmark, 5000 | |
| Investigational Site Number 208001 | Recruiting |
| Vejle, Denmark, 7100 | |
| Investigational Site Number 208010 | Recruiting |
| Viborg, Denmark, 8800 | |
| Estonia | |
| Investigational Site Number 233004 | Recruiting |
| Tallinn, Estonia, 10138 | |
| Investigational Site Number 233002 | Recruiting |
| Tallinn, Estonia, 11913 | |
| Investigational Site Number 233005 | Recruiting |
| Tallinn, Estonia, 13419 | |
| Investigational Site Number 233001 | Recruiting |
| Tallinn, Estonia, 13415 | |
| Investigational Site Number 233003 | Recruiting |
| Tartu, Estonia, 51014 | |
| Hungary | |
| Investigational Site Number 348007 | Recruiting |
| Szekesfehervar, Hungary | |
| Israel | |
| Investigational Site Number 376004 | Recruiting |
| Afula, Israel, 18101 | |
| Investigational Site Number 376009 | Recruiting |
| Ashkelon, Israel, 78278 | |
| Investigational Site Number 376011 | Recruiting |
| Haifa, Israel, 31048 | |
| Investigational Site Number 376007 | Recruiting |
| Holon, Israel, 58100 | |
| Investigational Site Number 376021 | Recruiting |
| Holon, Israel, 58100 | |
| Investigational Site Number 376005 | Recruiting |
| Jerusalem, Israel, 91120 | |
| Investigational Site Number 376002 | Recruiting |
| Kfar Saba, Israel, 44281 | |
| Investigational Site Number 376008 | Recruiting |
| Safed, Israel, 13100 | |
| Investigational Site Number 376003 | Recruiting |
| Safed, Israel, 13100 | |
| Investigational Site Number 376022 | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| Investigational Site Number 380012 | Recruiting |
| Ferrara, Italy, 44100 | |
| Investigational Site Number 380011 | Recruiting |
| Grosseto, Italy, 58100 | |
| Investigational Site Number 380005 | Recruiting |
| Milano, Italy, 20100 | |
| Investigational Site Number 380009 | Recruiting |
| Zingonia-Osio Sotto, Italy | |
| Lithuania | |
| Investigational Site Number 440001 | Recruiting |
| Klaipeda, Lithuania, LT-91131 | |
| Investigational Site Number 440007 | Recruiting |
| Vilnius, Lithuania, 10309 | |
| Investigational Site Number 440002 | Recruiting |
| Vilnius, Lithuania, 08314 | |
| Investigational Site Number 440003 | Recruiting |
| Vilnius, Lithuania, 08661 | |
| Mexico | |
| Investigational Site Number 484004 | Recruiting |
| Culiacan, Mexico, 80020 | |
| Investigational Site Number 484018 | Recruiting |
| Monterrey, Mexico, 64060 | |
| New Zealand | |
| Investigational Site Number 554001 | Recruiting |
| Christchurch, New Zealand | |
| Investigational Site Number 554004 | Recruiting |
| Hamilton, New Zealand, 3200 | |
| Investigational Site Number 554007 | Recruiting |
| New Plymouth, New Zealand | |
| Investigational Site Number 554002 | Recruiting |
| Otahuhu, New Zealand, 1701 | |
| Singapore | |
| Investigational Site Number 702003 | Recruiting |
| Yishun, Singapore, 768828 | |
| Slovakia | |
| Investigational Site Number 703001 | Recruiting |
| Bardejov, Slovakia, 085 01 | |
| Investigational Site Number 703011 | Recruiting |
| Bratislava, Slovakia, 81104 | |
| Investigational Site Number 703013 | Recruiting |
| Bratislava, Slovakia, 84107 | |
| Investigational Site Number 703009 | Recruiting |
| Kosice, Slovakia, 04001 | |
| Investigational Site Number 703016 | Recruiting |
| Kosice, Slovakia, 040 01 | |
| Investigational Site Number 703002 | Recruiting |
| Kosice, Slovakia | |
| Investigational Site Number 703007 | Recruiting |
| Kosice, Slovakia, 04022 | |
| Investigational Site Number 703019 | Recruiting |
| Kosice, Slovakia, 04011 | |
| Investigational Site Number 703012 | Recruiting |
| Kralovsky Chimec, Slovakia, 07701 | |
| Investigational Site Number 703017 | Recruiting |
| Levice, Slovakia, 93401 | |
| Investigational Site Number 703006 | Recruiting |
| Lucenec, Slovakia, 98401 | |
| Investigational Site Number 703010 | Recruiting |
| Lucenec, Slovakia, 98401 | |
| Investigational Site Number 703003 | Recruiting |
| Nitra, Slovakia, 950 01 | |
| Investigational Site Number 703004 | Recruiting |
| Presov, Slovakia, 08001 | |
| Investigational Site Number 703018 | Recruiting |
| Svidnik, Slovakia, 08901 | |
| Investigational Site Number 703005 | Recruiting |
| Zilina, Slovakia, 01001 | |
| South Africa | |
| Investigational Site Number 710002 | Recruiting |
| Durban, South Africa, 4320 | |
| Spain | |
| Investigational Site Number 724013 | Recruiting |
| Granada, Spain, 18012 | |
| Investigational Site Number 724003 | Recruiting |
| Huelva, Spain, 21005 | |
| Investigational Site Number 724031 | Recruiting |
| Madrid, Spain, 28040 | |
| United Kingdom | |
| Investigational Site Number 826012 | Recruiting |
| Chesterfield, United Kingdom, S44 5BL | |
| Investigational Site Number 826009 | Recruiting |
| Rotherham, United Kingdom, S60 2UD | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01663402 History of Changes |
| Other Study ID Numbers: | EFC11570, 2011-005698-21, U1111-1127-4323 |
| Study First Received: | August 8, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013