post-MI patients
Conditions
Interventions
investigational material(s)
Generic name etc : Canakinumab
INN of investigational material : Canakinumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration f
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Spontaneous MI at least 30 days before randomization. 3. hsCRP >= 2 mg/L
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) women 2. Women of child-bearing potential 3. 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 4. History or evidence of active tuberculosis (TB) infection Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Time to first occurrence of a major adverse cardiovascular event, which is a composite endpoint consisting of cardiovascular death, non-fatal MI, and stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - Time to the first occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, stroke, and hospitalization for unstable angina requiring unplanned revascularization. - Time to new onset type 2 diabetes among those with pre-diabetes at randomization. - Time to first occurrence of non-fatal MI, stroke, and all-cause mortality composite. - Time to all-cause mortality. | — |
Countries
Africa, Asia except Japan, Japan, North America, South America
Outcome results
None listed