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Clinical Trials List

Protocol NumberCACZ885M2301
NCT Number(ClinicalTrials.gov Identfier)NCT01327846

2011-04-01 - 2019-04-26

Phase III

Terminated14

ICD-10I70.90

Unspecified atherosclerosis

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Po-Hsun Huang 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 鄭書孟 無
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Kuan-Cheng Chang 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 翁國昌 無
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳清埤 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator WEN-TER Lai 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Zhih-Cherng Chen 無
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 曹玄明 無
National Yang-Ming University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 郭任遠 未分科
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 程俊傑 無
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 方志元 無
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator I-Chang Hsieh 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Juey-Jen Hwang 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 郭任遠 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Atherosclerosis

Objectives

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.

Test Drug

Canakinumab / ACZ885

Active Ingredient

Canakinumab / ACZ885

Dosage Form

Injection

Dosage

150 mg/1 ml；50 mg/0.5 ml

Endpoints

Primary Outcome Measures :
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 ]
Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.

Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery [ Time Frame: 24 months ]
Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits [ Time Frame: From randomization up to approximately 6 years ]

Inclution Criteria

Main Study 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
Substudy 1 Inclusion:

All Inclusion from Main Study
Acquisition of evaluable baseline MRI images of bilateral carotid arteries by the imaging core laboratory
Substudy 2 Inclusion:

All inclusion from Main Study
T2D at baseline per Main protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test
Willing to have the OGTT assessment started before 10 am

Exclusion Criteria

Main Study 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 Substudy 1 Exclusion
All Main exclusion
Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy
Patients with contraindications to MRI examination (brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body or other implanted body, tattoos, implanted insulin pump, metal shrapnel or bullet)
Patients prone to claustrophobia or known anxiety disorders
BMI > 40 kg/m2 Substudy 2 Exclusion
This sub-study does not have any additional exclusion criteria.

The Estimated Number of Participants

  • Taiwan

    500 participants

  • Global

    10000 participants

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