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

Sponsored by Novartis
This study is currently recruiting participants.

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 III

Eligibility

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

Physicians:
Ameer Kabour, MD
Raza Hashmi, MD
Tarif Kanaan, MD
Mohammad Alkhateeb, MD

Coordinators:
Coordinators:
Michelle Hickam, RN, BSN
Brenda Hoagland, RN, CCRC
Julie Neidhardt, RN, BSN

Please contact us at 419-251-4919 for further information about this study.