A randomized, double-blind, placebo-controlled, eventdriven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP
- Conditions
- atherosclerosisMedDRA version: 14.1Level: PTClassification code 10066537Term: Atherosclerosis prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-022970-14-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10061
- 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4746
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2556
- Pregnant or nursing (lactating) women - Women of child-bearing potential - Any of the following concomitant diseases: 1. Planned coronary revascularization (PCI or CABG) 2. Major non-cardiac surgical or endoscopic procedure within past 6 months 3. Multi-vessel CABG surgery within the past 3 years Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA] 4. Uncontrolled hypertension 5. Uncontrolled diabetes - History or evidence of active tuberculosis (TB) infection Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method