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)
- Conditions
- secondary prevention after myocardial infarction10011082
- Registration Number
- NL-OMON35757
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 260
* 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).
* 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 < 5 years, other then vascular disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Occurrence of cardiovascular death, non-fatal MI and stroke.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Hospitalization for unstable angina requiring unplanned revascularizations,<br /><br>all-cause mortality, new onset type 2 diabetes, adverse events.</p><br>