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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by McGill University
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Queen Elizabeth II Health Sciences Centre
Information provided by (Responsible Party):
Mark Eisenberg, McGill University
ClinicalTrials.gov Identifier:
NCT00794573
First received: November 19, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: varenicline
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Smoking cessation rates [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking abstinence, ≥ 50% reduction in daily consumption of cigarettes, side effects, cumulative side effects, safety [ Time Frame: Smoking abstinence: 52 weeks. Side effects and safety: 4, 12, 24, and 52 weeks. Cumulative side effects: 12 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794573

Contacts
Contact: Mark J Eisenberg, MD, MPH (514) 340-8222 ext 3564 mark.eisenberg@mcgill.ca
Contact: Sarah B Windle, MPH (514) 340-8222 ext 5830 sarah.windle@mail.mcgill.ca

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Iqbal Bata, MD    902.473.8623    Iqbal.Bata@cdha.nshealth.ca   
Principal Investigator: Iqbal Bata, MD         
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Beth Abramson, MD MSc    (416) 864-5968    abramsonb@smh.toronto.on.ca   
Principal Investigator: Beth Abramson, MD MSc         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Minakshi Madan, MD MHS    (416) 480-4119    mina.madan@sunnybrook.ca   
Principal Investigator: Minakshi Madan, MD MHS         
Canada, Quebec
SMBD - Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T1E2
Contact: Mark J Eisenberg, MD MPH    (514) 340-8222 ext 3564    mark.eisenberg@mcgill.ca   
Contact: Sarah B Windle, MPH    (514) 340-8222 ext 5830    sarah.windle@mail.mcgill.ca   
Principal Investigator: Mark J Eisenberg, MD MPH         
Sponsors and Collaborators
Mark Eisenberg
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Queen Elizabeth II Health Sciences Centre
Investigators
Principal Investigator: Mark J Eisenberg, MD, MPH SMBD - Jewish General Hospital
  More Information

No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Eisenberg, Professor of Medicine, Divisions of Cardiology and Clinical Epidemiology, McGill University
ClinicalTrials.gov Identifier: NCT00794573     History of Changes
Other Study ID Numbers: EVITA
Study First Received: November 19, 2008
Last Updated: December 10, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by McGill University:
Smoking Cessation
Cardiac Population
Acute Coronary Syndrome
Varenicline
Champix

Additional relevant MeSH terms:
Smoking
Acute Coronary Syndrome
Habits
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014