Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Main Study (CACZ885M2301): The purpose of the pivotal phase 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. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. 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.

Official 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

Details

There will be a seamless transition from the pivotal phase to the extension phase of the main study. LPLV of the pivotal phase will be in 02/2017.

Keywords

Atherosclerosis Cardiovascular Death Myocardial Infarction Stroke Canakinumab IL-1B hsCRP Antibodies, Monoclonal Standard of care Canakinumab Dose 50 mg Canakinumab Dose 150 mg Canakinumab Dose 300 mg

Eligibility

For people ages 18 years and up

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

Locations

  • Novartis Investigative Site
    San Francisco California 94143-0792 United States
  • Novartis Investigative Site
    Walnut Creek California 94598 United States
  • Novartis Investigative Site
    Visalia California 93291 United States
  • Novartis Investigative Site
    Los Gatos California 95032 United States
  • Novartis Investigative Site
    Santa Rosa California 95405 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01327846
Phase
Phase 3
Study Type
Interventional
Last Updated
August 16, 2018