Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: varenicline; placebo
Intervention description: 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.; 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Cardiac Population; Acute Coronary Syndrome; Varenicline; Champix

Summary:

      The EVITA study is a clinical trial that will test the effect of varenicline (Champix™), a
      new drug used to help people quit smoking, in patients who have suffered a heart attack.
      Varenicline has been recently shown to increase the number of otherwise healthy people who
      quit smoking compared to placebo (sugar pill). Although varenicline has been shown to reduce
      smoking in healthy populations, its effectiveness in patients recovering from a heart attack
      is unknown. The EVITA trial will help answer this question.

      A total of 300 patients who have recently suffered a heart attack and are active smokers will
      be recruited in the study. For twelve weeks, half the patients will receive varenicline and
      the other half will receive placebo pills. Patients will be followed for a period of 12
      months. During this time, patients will receive telephone calls and go to clinic visits in
      order to assess if they are smoking. These follow-ups will also assess any side effects and
      clinical events such as another heart attack or hospitalization that patients may have had.
      Smoking cessation will be checked using exhaled carbon monoxide readings and self-reports.

      The EVITA trial will be the first study to examine the use of varenicline in patients who
      have recently had a heart attack. These patients, if they continue to smoke, are at high risk
      of having another cardiac event. If varenicline is shown to be useful in this population, it
      will have a major impact on prevention of cardiac events in patients who have suffered a
      heart attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active smoker, greater than or equal to 10 cigarettes per day, on average, for the
             past year.

          -  Age greater than or equal to 18 years.

          -  Motivated to quit smoking.

          -  Able to understand and to provide informed consent in English or French.

          -  Likely to be available for follow-up.

          -  Suffered an ACS, including myocardial infarction (MI) or unstable angina (UA) with
             significant coronary artery disease, and currently hospitalized or at discharge from
             current hospitalization.

        MI is defined as positive Troponin T, Troponin I, or CK-MB levels and ≥ 1 of the following:

          1. Ischemic symptoms (i.e. typical chest pain) for at least 20 minutes.

          2. Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or
             depression).

          3. Development of pathological Q waves on the ECG.

        UA with significant coronary artery disease is defined as all of the following:

          1. Negative Troponin T, Troponin I, or CK-MB levels;

          2. Ischemic symptoms (i.e. typical chest pain) for at least 20 minutes;

          3. ECG changes indicative of ischemia (ST-segment changes); and

          4. At least one lesion ≥ 50% on angiogram performed during the current hospitalization.

        Exclusion Criteria:

          -  Medical condition with a prognosis of < 1 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.

          -  Diagnosis of major depression (requiring medication) in the previous 5 years or
             diagnosis of two or more lifetime episodes of major depression (requiring medication)

          -  A total of 5 or more responses (one of which includes question 1 or 2) of "more than
             half the days" or "nearly every day" to the questions on the PHQ-9 questionnaire.

          -  History of suicidal events (previous suicide attempt, suicidal ideation) or family
             history of suicide.

          -  History of or current panic disorder, psychosis, bipolar disease, or dementia.

          -  Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment (AST
             or ALT levels greater than or equal to 2 times upper limit of normal prior to
             admission for ACS).

          -  Renal impairment with creatinine levels greater than or equal to 2 times the upper
             limit of normal.

          -  Excessive alcohol consumption defined as greater than or equal to 14 alcoholic drinks
             per week.

          -  Use of any illegal drugs in the past year (e.g. cocaine, heroin, opiates).

          -  Use of any marijuana or other tobacco products during the study.

          -  Current use of over-the-counter stimulants (e.g. ephedrine, phenylephrine) or
             anorectics.