Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial (EVITA)

April 26, 2019 updated by: Mark Eisenberg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: 1. The primary objective of the Evaluation of Varenicline (Champix™) in SmokIng Cessation for PaTients Post-Acute Coronary Syndrome (EVITA) Trial is to evaluate the impact of varenicline on smoking cessation rates at 24 weeks following an enzyme-positive acute coronary syndrome (ACS).

2. The secondary objectives are to examine the efficacy of varenicline on smoking cessation rates and daily cigarette reduction at 52 weeks, and to determine the safety of varenicline in patients following an ACS.

Rationale: Patients who continue smoking after an acute coronary syndrome (ACS) have a 35% increased risk of reinfarction or death compared with those who quit. Many patients attempt to stop smoking after an ACS, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, physicians are reluctant to use a nicotine-based therapy because of its hemodynamic effects. Varenicline has been recently shown to improve abstinence rates in healthy young smokers compared to bupropion (Zyban™) and placebo. Although varenicline has successfully been shown to reduce smoking rates in healthy young populations, its efficacy in the setting of patients recovering from an ACS is unknown.

Methods: The EVITA Trial will directly compare the efficacy of varenicline versus placebo as a means of reducing smoking rates in patients following an ACS. The trial will be a multi-center effort, coordinated from the Jewish General Hospital/McGill University (Montreal, Quebec). A total of 300 patients will be randomized following an ACS but before hospital discharge. While in-hospital, patients will quit smoking and they will be instructed to not restart smoking following discharged. Half the patients will receive varenicline for 12 weeks and the other half will receive placebo pills for 12 weeks. Patients receiving varenicline will be given 1.0 mg twice a day during the 12-week treatment period. Study nurses will perform telephone follow-ups with the patients at weeks 1, 2 and 8, and patients will return for clinic visits at weeks 4, 12, 24, and 52. Smoking abstinence will be assessed at follow-up clinic visits.

The primary endpoint will be smoking abstinence at 24 weeks. Smoking abstinence will be defined as complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide ≤ 10 ppm. The secondary endpoints (smoking abstinence at 52 weeks, side effects of varenicline in patients following an ACS, percent of patients attaining a ≥ 50% reduction in daily consumption of cigarettes at 52 weeks, and clinical events following initiation of treatment) will be measured at 1, 2, 4, 8, 12, 24, and 52 weeks. The occurrence of clinical events will be based on the observed frequency of composite events including death, myocardial infarction, and hospitalization for unstable angina. Withdrawal symptoms and number of cigarettes smoked will also be assessed by the use of questionnaires. The EVITA trial will require 36 months for completion: 3 months for preparation, 18 months for patient enrollment, 12 months for follow-up, and 3 months for data analysis and manuscript preparation.

Significance: The EVITA trial will be the first to examine the efficacy of varenicline in a group of patients who have suffered an ACS. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If varenicline is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer an ACS.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • SMBD - Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicline
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.
Drug: varenicline
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.
Other Names:
  • Champix (Canada)
  • Chantix (USA)
Placebo Comparator: Sugar pill
placebo for 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.
Other: placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Smoking Abstinence
Time Frame: 24 weeks
7-day point prevalence abstinence at week 24, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
24 weeks
Continuous Smoking Abstinence
Time Frame: 24 weeks
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 24.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Smoking Abstinence
Time Frame: 52 weeks
7-day point prevalence abstinence at week 52, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
52 weeks
Continuous Smoking Abstinence
Time Frame: 52 weeks
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 52.
52 weeks
7-Day Point Prevalence Smoking Abstinence
Time Frame: 12 weeks
7-day point prevalence abstinence at week 12, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
12 weeks
Continuous Smoking Abstinence
Time Frame: 12 weeks
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 12.
12 weeks
7-Day Point Prevalence Smoking Abstinence
Time Frame: 4 weeks
7-day point prevalence abstinence at week 4, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
4 weeks
Continuous Smoking Abstinence
Time Frame: 4 weeks
Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 4.
4 weeks
Reduction in Daily Cigarette Consumption by 50% or Greater
Time Frame: 52 weeks
52 weeks
Reduction in Daily Cigarette Consumption by 50% or Greater
Time Frame: 24 weeks
24 weeks
Reduction in Daily Cigarette Consumption by 50% or Greater
Time Frame: 12 weeks
12 weeks
Reduction in Daily Cigarette Consumption by 50% or Greater
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark Eisenberg

Collaborators

Sunnybrook Health Sciences Centre
Unity Health Toronto
Queen Elizabeth II Health Sciences Centre

Investigators

  • Principal Investigator: Mark J Eisenberg, MD, MPH, SMBD - Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 20, 2008

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVITA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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