Home » Trials » SLCTR/2013/034


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

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SLCTR Registration Number

SLCTR/2013/034


Date of Registration

18 Nov 2013

The date of last modification

Mar 03, 2019


View original TRDS



Application Summary


Scientific Title of Trial

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


Public Title of Trial

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


Disease or Health Condition(s) Studied

Hypercholesterolemia, Acute Coronary Syndromes


Scientific Acronym

ODYSSEY OUTCOMES


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

EFC11570 (Internal Protocol Number)NCT01663402 (clinicaltrials.gov)


Trial Details


What is the research question being addressed?

What is the effectiveness of the lipid lowering agent SAR236553 compared to 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 intensive statin therapy


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 3


Intervention(s) planned

Consenting patients will be randomized into two arms. The intervention arm will receive SAR236553 - 75mg/150mg as a subcutaneous injection every two weeks until a study end-point is reached. It is expected that that each patient will receive the allocated treatment for at least 24 months.

The cotrol arm will receive a standardized placebo as a subcutaneous injection every two weeks for (please give duration).

Standard therapy will be continued for both arms.


Inclusion criteria

  1. Recent acute coronary syndrome (4-16 weeks prior to randomization)
  2. On intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s).
  3. Patients not adequately controlled (as defined by at least one of the following: LDL-C ? 70 mg/dL [?1.81 mmol/L], ApoB ?80 mg/dL [?0.8 mmol/L], or non-HDL-C ?100 mg/dL [?2.59 mmol/L]) at the the qualifying Visit (V2), despite evidence-based lipid lowering therapy (including intensive atorvastatin/rosuvastatin therapy or maximally tolerated dose of either of these 2 statins, or other non statin LMTs).
  4. Signed written informed consent.

Exclusion criteria

  1. All of the following: LDL-C <70 mg/dL (<1.81 mmol/L), ApoB < 80 mg/dL (< 0.8 mmol/L), and non-HDL-C <100 mg/dL (<2.59 mmol/L) at the qualifying Visit (V2).
  2. Age <40 years.
  3. Patients who have experienced an ACS event more than 16 weeks (+ 3 days) prior to randomization visit (V3).
  4. Not on a stable dose of atorvastatin or rosuvastatin for at least 2 weeks prior to qualifying visit (V2 or V2b) and at least 4 weeks prior to randomization visit (V3), or not on a stable dose of any other authorized LMT for at least 4 weeks prior to qualifying visit (V2 or V2b) and at least 6 weeks prior to randomization visit (V3, Month 0).
  5. Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) at V2 or V3.
  6. New York Heart Association Class III or IV congestive heart failure persisting despite treatment or if measured LVEF <25%.
  7. Known history of hemorrhagic stroke.
  8. Fasting serum triglycerides (TG) >400 mg/dL (>4.52 mmol/L) prior to randomization.
  9. Known history of untreated hypothyroidism.
  10. Patient who has been previously treated with at least one dose of SAR236553 or any other anti-PCSK9 monoclonal antibody in other clinical trials.
  11. Laboratory findings measured during screening and before randomization visit: Positive test for hepatitis B surface antigen and/or hepatitis C antibody, Triglycerides (TG) > 400mg/dL (>4.52 mmol/L) (1 repeat lab allowed), Positive serum or urine pregnancy test in females of childbearing potential, eGFR <30 mL/min/1.73 m² according to 4-variable MDRD Study equation (calculated by central lab), ALT or AST >3 x ULN on most recent determination prior to randomization (1 repeat lab is allowed), CPK >3 x ULN on most recent determination prior to randomization (1 repeat lab is allowed).

  12. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, patients with short life expectancy.

  13. Patients considered by the Investigator or any sub-Investigator as inappropriate for this study for any reason, eg: •Those deemed unable to meet specific protocol requirements, such as scheduled visits. •Investigator or any sub-Investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol, etc. •Presence of any other conditions (eg, geographic, social….) actual or anticipated, that the Investigator feels would restrict or limit the patient’s participation for the duration of the study



Primary outcome(s)

1.

CHD death

[

From randomization up to 64months

]
2.

Any non-fatal MI

[

From randomization up to 64months

]
3.

Fatal and non-fatal ischemic stroke

[

From randomization up to 64months

]
4.

Unstable angina requiring hospitalization

[

From randomization up to 64months

]

Secondary outcome(s)

1.

The first occurrence of any CHD event 2. 3. Any CV event, 4. , 5.

[

Every month up to completion 64 months post randomization

]
2.

The first occurrence of Major CHD event

[

Every month up to completion 64 months post randomization

]
3.

The first occurrence of Any CV event

[

Every month up to completion 64 months post randomization

]
4.

Composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke

[

Every month up to completion 64 months post randomization

]
5.

All cause mortality

[

Every month up to completion 64 months post randomization

]

Target number/sample size

300


Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Province of China, Thailand, Turkey, Ukraine, United Kingdom, United States


Anticipated start date

2013-11-18


Anticipated end date

2018-03-15


Date of first enrollment

2013-11-28


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

Sanofi-Aventis


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2013-06-12


Approval number

P108/06/2013


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Sepalika Mendis
Coordinating Principal Investigator and Consultant Cardiologist
Institute of Cardiology, National Hospital of Sri Lanka
Tel: 0094112691111 (Ext – 2643)
Mob: 0094777385747
fax: 0094112692823
sepalikamendis@yahoo.com

Contact Person for Public Queries

Dr. Sepalika Mendis
Coordinating Principal Investigator and Consultant Cardiologist
Institute of Cardiology, National Hospital of Sri Lanka
Tel: 0094112691111 (Ext – 2643)
Mob: 0094777385747
Fax: 0094112692823
sepalikamendis@yahoo.com


Primary study sponsor/organization

Sanofi-Aventis

I, avenue Pierre Brossolette, 91380 Chilly-Mazarin, France
+33 1 60 49 77 77
+33 1 60 49 77 77

www.sanofi.com

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results