Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Diseas... | Recruiting
Cardiovascular Risk Reduction Study... | Recruiting
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
CANTOS
Trial Source

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Medical Conditions
  • Atherosclerosis
Novartis Pharmaceuticals
1-888-669-6682
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT01327846
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Main Study (CACZ885M2301) The purpose of this trial is to test the hypothesis that canakinumab treatment of patients with MI at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events.

Sub-study 1 (CACZ885M2301S1) The purpose of this sub-study is to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS).

Sub-study 2 (CACZ885M2301S2) The purpose of this CANTOS sub-study is to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care increases insulin secretion and insulin sensitivity.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Canakinumab, Drug : Placebo

Study Arm Groups : Canakinumab 50 mg, Canakinumab Dose 150 mg, Canakinumab Dose 300 mg, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Main:Time to first occurrence of major adverse cardiovascular event, which is a composite of CV death, non-fatal MI, and stroke.; 36 months; Substudy 1; Change from baseline in carotid plaque burden in the bifurcation region of the index carotid artery; 36 months; Substudy 2; Change from baseline of the insulin secretion rate (ISR) relative to glucose 0-30 min defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 averaged across the yearly visits.; 36 months
Secondary Outcome Measures
    Main:Time to first occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, stroke and hospitalization for unstable angina requiring unplanned revascularization.; 36 months; Main:Time to new onset type 2 diabetes among patients with pre-diabetes at randomization.; 36 months; Main:Time to first occurrence of non-fatal MI, stroke and all-cause mortality composite.; 36 months; Main: Time to all-cause mortality.; 36 months; Substudy 1; Change from baseline of the total vessel wall area at Month 3 of the index carotid artery.; 36 months; Substudy 1; Mean total vessel wall area across the left and right carotid artery at Month 3 and Month 24.; 36 months; Substudy 1; Change from baseline in corresponding total vessel wall area in the left and right carotid arteries.; 36 months; Substudy 1; The existence of a baseline total vessel wall area by treatment interaction as well as the consistency of the treatment effect across subgroups.; 36 months; Substudy 2; Change from baseline in insulin sensitivity index.; 36 months; Substudy 2; Change from baseline in OGTT stimulated area under curve (AUC) 0-120 min of glucose concentration, insulin concentration, pro-insulin concentration, and insulin concentration/glucose concentration ratio.; 36 months; Substudy 2; Change from baseline in fasting pro-insulin concentration /insulin concentration ratio.; 36 months; Substudy 2; Change from baseline in OGTT stimulated area under the curve (AUC) 0-120 min of C-peptide concentration.; 36 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
10000
Participant Inclusion Criteria
    Main Study Inclusion Criteria:

    - Written informed consent

    - Male, or Female of non-child-bearing potential

    - Age ≥ 18 years.

    - Spontaneous MI at least 30 days before randomization. hsCRP ≥ 2 mg/L

    Substudy 1 Inclusion:

    - All Inclusion from Main Study

    - Acquisition of evaluable baseline MRI images of bilateral carotid arteries by the imaging core laboratory

    Substudy 2 Inclusion:

    - All inclusion from Main Study

    - T2D at baseline per Main protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test

    - Willing to have the OGTT assessment started before 10 am

    Main Study Exclusion Criteria:

    - Pregnant or nursing (lactating) women

    - Women of child-bearing potential

    - Any of the following concomitant diseases

    - Planned coronary revascularization (PCI or CABG)

    - Major non-cardiac surgical or endoscopic procedure within past 6 months

    - Multi-vessel CABG surgery within the past 3 years

    - Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA].

    - Uncontrolled hypertension

    - Uncontrolled diabetes

    - History or evidence of active tuberculosis (TB) infection Substudy 1 Exclusion

    - All Main exclusion

    - Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy

    - Patients with contraindications to MRI examination (brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body or other implanted body, tattoos, implanted insulin pump, metal shrapnel or bullet)

    - Patients prone to claustrophobia or known anxiety disorders

    - BMI > 40 kg/m2 Substudy 2 Exclusion

    - This sub-study does not have any additional exclusion criteria. Other protocol-defined inclusion/exclusion criteria may apply
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Bordesley Green
B9 5SS
Royal Devon and Exeter Hospital
Exeter
England
EX2 5DW
Worcester Royal Hospital
Worcester
England
WR5 1DD
Southern General Hospital
Glasgow
Scotland
G51 4TF
Birmingham
B15 2TH
Musculoskeletal Department; Freeman Hospital
Newcastle upon Tyne
NE7 7DN
Clinical Trials Unit; Main Hospital; Salford Rooyal NHS Foundation Trust
Salford
M6 8HD
Nottingham
Nottinghamshire
NG5 1PB
Dundee
DD1 9SY
Basingstoke
RG24 9NA
Norwich
NR4 7UY
York
YO31 8HE
CPSResearch
Glasgow
Scotland
G20 0XA
Sheffield Kidney Institute
Sheffield
S5 7AU
Taunton
TA1 5DA
Atherstone
Warwickshire
CV9 1EU
Bristol
BS2 8HW
GRACE Network in Cardiff
Cardiff
CF5 4AD
Local Institution
Newport
Isle of Wight
PO30 5TG
Saint Just
Cornwall
TR19 7HX
Study Site - 24010
Leicester
Leicestershire
LE3 9QP
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barnet
Herts
EN5 3DJ
GSK Investigational Site
Manchester
Lancashire
M15 6SX
Synexus Lancashire Clinical Research Center
Buckshaw Village
Lancashire
PR7 7NA
Birmingham
B15 2SQ
Chesterfield
Derbyshire
S40 4AA
Cardiff
CF14 5GJ
Waterloo
L22 0LG
Novartis Investigative Site
Nottingham
Nottinghamshire
NG17 4JL
Royal Gwent Hospital, Department of Dermatology
Newport
NP20 2UB
Synexus Clinical Research
Glasgow
G20 0SP
Novartis Investigative Site
West Bromwich
B71 4HJ
Irvine
Ayrshire
KA12 0AY
Axbridge & Wedmore Medical Practice
Axbridge
Somerset
BS26 2BJ
Novartis Investigative Site
EC14 7BE
Synexus Thames Valley
Reading
RG2 0TG
Novartis Investigative Site
Chippenham
SN15 2SB
Novartis Investigative Site
Whitby
North Yorkshire
Y021 1SD
Novartis Investigative Site
Sandbach
CW11 1EQ
Novartis Investigative Site
Carshalton
SH5 1AA
Trial Contact(s)
Primary Trial Contact
Novartis Pharmaceuticals
1-888-669-6682
Other Trial Contacts
Novartis Pharmaceuticals
Countries Recruiting
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Estonia, Germany, Greece, Guatemala, Hungary, Iceland, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Turkey, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomized, Double-blind, Placebo-controlled, Event Driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-Myocardial Infarction Patients With Elevated hsCRP Including Substudies to Evaluate the Effect of Canakinumab on Carotid Atherosclerosis, and on Glucose Control Following OGTT in T2DM
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CACZ885M2301
Sponsor(s)
Novartis Pharmaceuticals
Key Dates

Recruitment Start Date

Apr 2011

Recruitment End Date

Apr 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

29 Mar 2011

Date updated in source

05 Apr 2016