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 (CANTOS study, CACZ885M2301)

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 (CANTOS study, CACZ885M2301) - CANTOS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35757

Enrollment

260

Registered

2011-07-29

Start date

2011-09-12

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

secondary prevention after myocardial infarction

Interventions

Treatment with canakinumab or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Females (non-child-bearing potential or adequate contraception) and males *18 years of age. * MI with or without ST elevation (detailed criteria see protocol) at least 30 days before randomization. * hsCRP * 2 mg/L at prescreening (* 28 days after MI or PCI).

Exclusion criteria

Exclusion criteria: * Pregnancy, breast feading. * Planned CABG or PCI. * 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. * Uncontrolled hypertension. * Uncontrolled diabetes. * Prior malignancy other than basal cell skin carcinoma. * History, evidence of or risk factors for active TB infection (see protocol for details). * History of ongoing, chronic or recurrent infectious disease. * Patients with suspected or proven immunocompromised state. * Live vaccinations within 3 months prior to the randomization visit or live vaccinations planned during the trial. * Any biologic drugs targeting the immune system. * Any life threatening condition with life expectancy

Design outcomes

Primary

Measure	Time frame
Occurrence of cardiovascular death, non-fatal MI and stroke.	—

Secondary

Measure	Time frame
Hospitalization for unstable angina requiring unplanned revascularizations, all-cause mortality, new onset type 2 diabetes, adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)