CV Risk Reduction sub-study (Reduction in Recurrent Major CV disease)

Conditions: atherosclerosis
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-003010-14-SK

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

• Written informed consent form
• Meet main study eligibility criteria listed in Section 4.1 and 4.2 of protocol CACZ885M2301 and agreed to participate in CANTOS main study
• Acquisition of evaluable baseline MRI images of bilateral carotid arteries by the imaging core laboratory
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

All main study exclusion
•Pregnant or nursing (lactation) women
• Women of child-bearing potential
• Any of the following concomitent diseases:
1. Planned coronary revascularization
2. major non cardiac surgical or endoscopic procedure within past 6 months

• Patients with prior history of carotid angioplasty, stenting or carotid atherectomy
• Patients with contraindications to MRI examination
• Patients prone to claustrophobia or known anxiety disorders
• BMI >40kg/m2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months compared with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS);Secondary Objective: Not applicable;Primary end point(s): Change from baseline in carotid plaque burden in the bifurcation region of the index carotid artery;Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change from baseline of the total vessel wall area at month 3 of the index carotid artery<br>• Mean total vessel wall area across the left and right carotid artery at Month 3 and Month 24<br>• Change from baseline in corresponding total vessel wall area in the left and right carotid arteries<br>• The existence of a baseline total vessel wall area by treatment interaction as well as the consistency of the treatment effect across subgroups.;Timepoint(s) of evaluation of this end point: 36 months