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
