Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

Recruiting

• Source

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  Public Title	Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
  Acronym	CANTOS
  Source of Record URL	http://clinicaltrials.gov/show/NCT01327846

• Trial

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  Health Condition(s) or Problem	Atherosclerosis
  Lay 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. (from ClinicalTrials.gov)
  Who can enter the trial	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
  Who cannot enter the trial	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
  What will happen	Drug; Canakinumab; Canakinumab 50 mg; Canakinumab Dose 150 mg; Canakinumab Dose 300 mg; Drug; Placebo; Placebo
  Primary aim	Main:Time to first occurrence of major adverse cardiovascular event, which is a composite of CV death, non-fatal MI, and stroke.; Substudy 1; Change from baseline in carotid plaque burden in the bifurcation region of the index carotid artery; Substudy 2; Change from baseline of the insulin secretion rate (ISR) relative to glucose 0-30 min defined as F30 = AUCISR 0-30 / AUCGluc 0-30 averaged across the yearly visits.
  Secondary Aim	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; No; Main:Time to new onset type 2 diabetes among patients with pre-diabetes at randomization.; 36 months; No; Main:Time to first occurrence of non-fatal MI, stroke and all-cause mortality composite.; 36 months; No; Main: Time to all-cause mortality.; 36 months; No; Substudy 1; Change from baseline of the total vessel wall area at Month 3 of the index carotid artery.; 36 months; No; Substudy 1; Mean total vessel wall area across the left and right carotid artery at Month 3 and Month 24.; 36 months; No; Substudy 1; Change from baseline in corresponding total vessel wall area in the left and right carotid arteries.; 36 months; No; 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; No; Substudy 2; Change from baseline in insulin sensitivity index.; 36 months; No; 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; No; Substudy 2; Change from baseline in fasting pro-insulin concentration /insulin concentration ratio.; 36 months; No; Substudy 2; Change from baseline in OGTT stimulated area under the curve (AUC) 0-120 min of C-peptide concentration.; 36 months; No
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England, Scotland, Wales
  Location	Penzance, Basingstoke, Newport, Salford, Whitby , Nottingham, Dundee, Axbridge, Taunton, Atherstone, Barnet, Birmingham, Bristol, Cardiff, London, Sandbach, Chesterfield, Chorley, Exeter, Glasgow, Irvine, Leicester, Liverpool, Manchester, Newcastle upon Tyne, Norwich, Sheffield, West Bromwich, Worcester, York

• Contact

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  Contact for Public Queries	Novartis Pharmaceuticals 1-888-669-6682 Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
  Contact for Scientific Queries	Sorry, not currently available