Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01327846

Purpose

The purpose of this trial is to test the hypothesis that canakinumab treatment of patients with MI at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events.

Condition	Intervention	Phase
Atherosclerosis	Drug: Canakinumab Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Heart Attack

Drug Information available for: Canakinumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Time to first occurrence of a major adverse cardiovascular event, which is a composite endpoint consisting of cardiovascular death, non-fatal MI, and stroke [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to the first occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, stroke, and hospitalization for unstable angina requiring unplanned revascularization [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Time to new onset type 2 diabetes among those with pre-diabetes at randomization [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Time to first occurrence of non-fatal MI, stroke, and all-cause mortality composite [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Time to all-cause mortality [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	17200
Study Start Date:	April 2011
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Canakinumab Dose 1	Drug: Canakinumab
Experimental: Canakinumab Dose 2	Drug: Canakinumab
Experimental: Canakinumab Dose 3	Drug: Canakinumab
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant or nursing (lactating) women
Women of child-bearing potential
Any of the following concomitant diseases
Planned coronary revascularization (PCI or CABG)
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 (HF) (New York Heart Association [NYHA].
Uncontrolled hypertension
Uncontrolled diabetes
History or evidence of active tuberculosis (TB) infection

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327846

Contacts

Contact: Novartis Pharmaceuticals

+1(862)778-8300

Show 1131 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ridker PM, Thuren T, Zalewski A, Libby P. Interleukin-1? inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS). Am Heart J. 2011 Oct;162(4):597-605. Epub 2011 Sep 14.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01327846 History of Changes
Other Study ID Numbers:	CACZ885M2301, 2010-022970-14
Study First Received:	March 29, 2011
Last Updated:	May 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Cardiovascular Death
Myocardial Infarction
Stroke

Canakinumab
IL-1B
hsCRP

Additional relevant MeSH terms:

Atherosclerosis
Myocardial Infarction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

Myocardial Ischemia
Heart Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012