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Cardiovascular Risk Reduction...

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

Last Updated: 2020-01-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10066 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-11

Study Completion Date

2019-04-14

Brief Summary

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Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could 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 was 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 was 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 could increase insulin secretion and insulin sensitivity.

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Detailed Description

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Sub-study 1 and 2 were terminated prior to data collection from subjects. However, there is an ongoing extension trial where patients are receiving open-drug label.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Intervention Type DRUG

Standard of care post-MI background therapy includes, but is not limited to, lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as appropriate

Interventions

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Canakinumab

Intervention Type DRUG

Placebo

Intervention Type DRUG

Standard of care

Standard of care post-MI background therapy includes, but is not limited to, lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as appropriate

Intervention Type DRUG

Other Intervention Names

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ACZ885

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada China Colombia Croatia Czechia Estonia Germany Greece Guatemala Hungary Iceland India Italy Japan Latvia Lithuania Mexico Netherlands Norway Peru Poland Puerto Rico Romania Russia Serbia Slovakia Slovenia South Africa South Korea Sweden Taiwan Turkey (Türkiye) United Kingdom