Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) | Not Recruiting
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
CANTOS
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Atherosclerosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01327846
Primary Trial ID Number
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
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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
Trial Location(s)
Research Site
Leicester
LE3 9QP
Salford Royal NHS Foundation Trust
Salford
Manchester
M6 8HD
Norfolk and Norwich University Hospital
Norwich
England
NR4 7UY
Pfizer Investigational Site
Sheffield
S5 7AU
Exeter
Devon
EX2 5DW
Birmingham
B15 2TH
GSK Investigational Site
Glasgow
G11 6NT
Nottingham University Hospitals, City Campus
Nottingham
NG5 1PB
Birmingham Heartlands Hospital
Birmingham
England
B9 5SS
The York Hospital, York Teaching Hospital NHS Foundation Trust
York
North Yorkshire
YO31 8HE
Cephalon Investigational Site
Newcastle upon Tyne
NE7 7DN
Royal Gwent Hospital
Newport
NP20 2UB
Musgrove Park Hospital
Taunton
England
TA1 5DA
Liverpool
L22 0LG
GSK Investigational Site
Manchester
M15 6SX
Novartis Investigative Site
Nottingham
Nottinghamshire
NG17 4JL
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke
England
RG24 9NA
St. Mary's Hospital
Newport
England
PO30 5TG
Site Reference ID/Investigator# 67784
Glasgow
G20 0XA
GSK Investigational Site
Cardiff
CF14 5GJ
Worcester
Worcestershire
WR5 1DD
Birmingham
B15 2SQ
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
Novartis Investigative Site
Cardiff
CF5 4AD
Novartis Investigative Site
Irvine
KA12 0AY
Synexus Lancashire Clinical Research Centre
Chorley
Lancashire
PR7 7NA
Synexus Scotland Clinical Research Centre
Glasgow
G20 0SP
Novartis Investigative Site
Wiltshire
SN15 2SB
Novartis Investigative Site
Berkshire
RG2 0TG
Novartis Investigative Site
Cheshire
CW11 1EQ
Chesterfield
Derbyshire
S40 4AA
Novartis Investigative Site
London
EC14 7BE
GSK Investigational Site
Axbridge
Somerset
BS26 2BJ
Novartis Investigative Site
Whitby
North Yorkshire
Y021 1SD
Novartis Investigative Site
Dundee
Perthshire
DD1 2BU
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, Estonia, Germany, Greece, Guatemala, Hungary, Iceland, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Turkey, United Kingdom
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 Assigned

29 Mar 2011

Last Updated

19 May 2015