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Acute Coronary SyndromePhase 3EVITANCT00794573

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

A Phase 3 study testing varenicline in people with Acute Coronary Syndrome, run by Mark Eisenberg at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
varenicline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
4 sitesCanada
Study dates
Sep 2009to Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • MI is defined as positive Troponin T, Troponin I, or CK-MB levels and ≥ 1 of the following:
  • Ischemic symptoms (i.e. typical chest pain) for at least 20 minutes.
  • Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression).
  • Development of pathological Q waves on the ECG.
  • UA with significant coronary artery disease is defined as all of the following:
  • Negative Troponin T, Troponin I, or CK-MB levels;
  • Ischemic symptoms (i.e. typical chest pain) for at least 20 minutes;
  • ECG changes indicative of ischemia (ST-segment changes); and
  • At least one lesion ≥ 50% on angiogram performed during the current hospitalization.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • SMBD - Jewish General Hospital

    Montreal, Quebec, H3T1E2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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.

Read the 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).

  1. 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.

Being tested
varenicline, placebo
Keywords
Smoking Cessation, Cardiac Population, Acute Coronary Syndrome, Varenicline, Champix
Medical subject headings
Acute Coronary Syndrome, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vareniclineDrug

    Also called Champix (Canada), Chantix (USA)

    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.

  • placeboOther

    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.

Study groups in NCT00794573
Study groupRoleWhat they receive
VareniclineExperimental0.5 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.
Receives: Drug: varenicline
Sugar pillPlacebo comparatorplacebo 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.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 7-Day Point Prevalence Smoking Abstinence

    7-day point prevalence abstinence at week 24, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

    Measured: 24 weeks

  2. Continuous Smoking Abstinence

    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.

    Measured: 24 weeks

Secondary outcomes (10)

  1. 7-Day Point Prevalence Smoking Abstinence

    7-day point prevalence abstinence at week 52, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

    Measured: 52 weeks

  2. Continuous Smoking Abstinence

    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.

    Measured: 52 weeks

  3. 7-Day Point Prevalence Smoking Abstinence

    7-day point prevalence abstinence at week 12, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

    Measured: 12 weeks

  4. Continuous Smoking Abstinence

    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.

    Measured: 12 weeks

  5. 7-Day Point Prevalence Smoking Abstinence

    7-day point prevalence abstinence at week 4, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm

    Measured: 4 weeks

  6. Continuous Smoking Abstinence

    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.

    Measured: 4 weeks

  7. Reduction in Daily Cigarette Consumption by 50% or Greater

    Measured: 52 weeks

  8. Reduction in Daily Cigarette Consumption by 50% or Greater

    Measured: 24 weeks

  9. Reduction in Daily Cigarette Consumption by 50% or Greater

    Measured: 12 weeks

  10. Reduction in Daily Cigarette Consumption by 50% or Greater

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2008 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00794573
Sponsor's protocol ID
EVITA
Acronym
EVITA
Status last verified
Apr 2019
First submitted
19 Nov 2008
Last updated
23 May 2019
Data monitoring committee
Yes

Publications

  • Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

    PubMed 34611902

  • Windle SB, Dehghani P, Roy N, Old W, Grondin FR, Bata I, Iskander A, Lauzon C, Srivastava N, Clarke A, Cassavar D, Dion D, Haught H, Mehta SR, Baril JF, Lambert C, Madan M, Abramson BL, Eisenberg MJ; EVITA Investigators. Smoking abstinence 1 year after acute coronary syndrome: follow-up from a randomized controlled trial of varenicline in patients admitted to hospital. CMAJ. 2018 Mar 26;190(12):E347-E354. doi: 10.1503/cmaj.170377.

    PubMed 29581161

  • Dehghani P, Habib B, Windle SB, Roy N, Old W, Grondin FR, Bata I, Iskander A, Lauzon C, Srivastava N, Clarke A, Cassavar D, Dion D, Haught H, Mehta SR, Baril JF, Lambert C, Madan M, Abramson BL, Eisenberg MJ. Smokers and Postcessation Weight Gain After Acute Coronary Syndrome. J Am Heart Assoc. 2017 Apr 18;6(4):e004785. doi: 10.1161/JAHA.116.004785.

    PubMed 28420644

  • Eisenberg MJ, Windle SB, Roy N, Old W, Grondin FR, Bata I, Iskander A, Lauzon C, Srivastava N, Clarke A, Cassavar D, Dion D, Haught H, Mehta SR, Baril JF, Lambert C, Madan M, Abramson BL, Dehghani P; EVITA Investigators. Varenicline for Smoking Cessation in Hospitalized Patients With Acute Coronary Syndrome. Circulation. 2016 Jan 5;133(1):21-30. doi: 10.1161/CIRCULATIONAHA.115.019634. Epub 2015 Nov 9.

    PubMed 26553744

  • Windle SB, Bata I, Madan M, Abramson BL, Eisenberg MJ. A randomized controlled trial of the efficacy and safety of varenicline for smoking cessation after acute coronary syndrome: design and methods of the Evaluation of Varenicline in Smoking Cessation for Patients Post-Acute Coronary Syndrome trial. Am Heart J. 2015 Oct;170(4):635-640.e1. doi: 10.1016/j.ahj.2015.07.010. Epub 2015 Jul 17.

    PubMed 26386786

  • Grandi SM, Shimony A, Eisenberg MJ. Bupropion for smoking cessation in patients hospitalized with cardiovascular disease: a systematic review and meta-analysis of randomized controlled trials. Can J Cardiol. 2013 Dec;29(12):1704-11. doi: 10.1016/j.cjca.2013.09.014.

    PubMed 24267809

  • Eisenberg MJ, Grandi SM, Gervais A, O'Loughlin J, Paradis G, Rinfret S, Sarrafzadegan N, Sharma S, Lauzon C, Yadav R, Pilote L; ZESCA Investigators. Bupropion for smoking cessation in patients hospitalized with acute myocardial infarction: a randomized, placebo-controlled trial. J Am Coll Cardiol. 2013 Feb 5;61(5):524-32. doi: 10.1016/j.jacc.2012.08.1030.

    PubMed 23369417

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing varenicline in people with Acute Coronary Syndrome, run by Mark Eisenberg at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-Day Point Prevalence Smoking Abstinence (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00794573, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.

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