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

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: Vascular imaging study employing MRI to demonstrate a decrease in carotid plaque burden in CANTOS patients - CANTOS sub-study 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003010-14-DE

Enrollment

330

Registered

2012-10-16

Start date

2013-01-23

Completion date

Unknown

Last updated

2014-03-17

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

Conditions

atherosclerosis

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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 330 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): • Change from baseline of the total vessel wall area at month 3 of the index carotid artery • Mean total vessel wall area across the left and right carotid artery at Month 3 and Month 24 • Change from baseline in corresponding total vessel wall area in the left and right carotid arteries • 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	—

Measure

Time frame

Secondary end point(s): • Change from baseline of the total vessel wall area at month 3 of the index carotid artery • Mean total vessel wall area across the left and right carotid artery at Month 3 and Month 24 • Change from baseline in corresponding total vessel wall area in the left and right carotid arteries • 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

—

Countries

Argentina, China, Germany, Hungary, Japan, Korea, Republic of, Slovakia, Taiwan, United Kingdom, United States

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026