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
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
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.
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.
Main Study Inclusion Criteria:
Substudy 1 Inclusion:
Substudy 2 Inclusion:
Main Study Exclusion Criteria:
CABA, Buenos Aires 1428, Argentina
CABA, Buenos Aires C1056ABJ, Argentina
CABA, Buenos Aires C1221ADC, Argentina
CABA, Buenos Aires C1425AGC, Argentina
CABA, Buenos Aires C1425BWO, Argentina
CABA, Buenos Aires C1440AAD, Argentina
CABA, Buenos Aires F.D. C1179AAB, Argentina
CABA, Buenos Aires F.D. C1430CKE, Argentina
CABA, C1119ACN, Argentina
Saint Stefan, Austria 8511, Austria
Ste-Foy, Quebec G1W 4R4, Canada
Xian, Shanxi 710004, China
Xian, Shanxi 710061, China
Baranquilla, Atlántico, Colombia
Cartegena, Colombia, Colombia
Baranquilla, Colombia
Prague 4 - Krc, 14059, Czechia
Viljandi County, 71024, Estonia
Muehlheim An Der Ruhr, North Rhine-Westphalia 45468, Germany
Huy / OT Anderbeck, 38836, Germany
Muehldorf Am Inn, 84453, Germany
Crete Heraklion, Greece 714 09, Greece
Heraklion Crete, Greece 711 10, Greece
Nyiregyháza, 4400, Hungary
Hyderabad, Andhra Pradesh 500001, India
Hyderabad, Andhra Pradesh, India
Nampally, Andhra Pradesh 500 001, India
Rajasthan, Rajasthan 324005, India
Onga-gun, Fukuoka 807-0051, Japan
Higashiibaraki-gun, Ibaraki 311-3193, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Chiyoda-ku, Tokyo 101-8309, Japan
Chiyoda-ku, Tokyo 101-8643, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Tg Mures, Mureș County 540136, Romania
Western Cape, 7130, South Africa
Berkshire, RG2 0TG, United Kingdom
Cheshire, CW11 1EQ, United Kingdom
Wiltshire, SN15 2SB, United Kingdom