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EVITA

EVITA

Objective

Status
Enrolling

Condition
Post Acute Coronary Syndrome (ACS)

Description

A double-blind, placebo-controlled design to examine the efficacy and safety of varenicline (Champix) as a means of reducing smoking rates in patients following an ACS.

Purpose

The purpose of this study is to determine whether varenicline helps patients stop smoking following a heart attack and to document its side effects. Varenicline has been approved by the FDA for healthy smokers and is available on the market.

Phase
III

Key Inclusion Criteria

  • Active smoker,  10 cigarettes per day, on average, for the past year.
  • Age  18 years.
  • Suffered an ACS, including myocardial infarction (MI) or unstable angina (UA) with significant coronary artery disease (CAD)
  • Motivated to quit smoking.
  • Able to provide informed consent.
  • Likely to be available for follow-up.
  • Other protocol-defined inclusion/exclusion may apply


Key Exclusion Criteria

  • Medical condition with a prognosis of less than one year.
  • Pregnant or lactating females.
  • Reported NYHA Class or Killip III or IV at randomization.
  • Previous use of varenicline.
  • Current use of any medical therapy for smoking cessation (e.g. BuSpar, doxepin, fluoxetine, nicotine gum, nicotine patch, or bupropion).
  • History of bulimia or anorexia nervosa.
  • Other protocol-defined inclusion/exclusion may apply  

ClinicalTrials.gov Identifier

NCT00794573

IRB Protocol Number
EVITA 125701
Principal Investigator(s)
Mohamad Cheblaco, MD

Clinical Trial Categories

  • Cardiology
Sponsor(s)
SMBD – Jewish General Hospital
Contact
Brenda Westacott, CCRC at 701-780-1845
or bwestacott@altru.org