Status
Enrolling
Condition
Atherosclerosis
Description
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
- 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
Purpose
The purpose of this trial is to test the hypothesis that canakinumab treatment of persons with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events.
Phase
III
Key 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
Key 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
Other protocol-defined inclusion/exclusion criteria may apply
ClinicalTrials.gov Identifier
NCT01327846
