Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

Conditions

• Atherosclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Canakinumab — DRUG
• Placebo — DRUG
• Standard of care — DRUG
  Standard of care post-MI background therapy includes, but is not limited to, lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as appropriate

Study Details

Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.

Key Dates

Start date

Apr 11, 2011

Status verified

Jan 2020

Primary completion

Mar 28, 2017

Completion

Apr 14, 2019

Study Design

Enrollment

10,066 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Canakinumab Dose 50 mg
  Pivotal Phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy
• Experimental: Canakinumab Dose 150 mg
  Pivotal Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy
• Experimental: Canakinumab Dose 300 mg
  Pivotal Phase: Blinded Canakinumab 300 mg quarterly subcutaneous (with one additional dose at week 2) + standard of care therapy. Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy
• Placebo Comparator: Placebo
  Pivotal Phase: Blinded matching placebo quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy

Primary Outcome Measure

Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components [ Time Frame: From randomization, to end of treatment plus 30 days, up to approximately 6 years ]

Locations (315)

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