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

NCT00794573 | Completed Phase 3 Results DMC

• 1 other identifier: EVITA
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Acute Coronary Syndrome

Keywords

Smoking Cessation; Cardiac Population; Acute Coronary Syndrome; Varenicline; Champix

Outcome Measures

Primary Outcomes (2)

• 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

  24 weeks

• 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.

  24 weeks

Secondary Outcomes (10)

• 7-Day Point Prevalence Smoking Abstinence

  52 weeks

• Continuous Smoking Abstinence

  52 weeks

• 7-Day Point Prevalence Smoking Abstinence

  12 weeks

• Continuous Smoking Abstinence

  12 weeks

• 7-Day Point Prevalence Smoking Abstinence

  4 weeks

Study Arms (2)

Varenicline

EXPERIMENTAL

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

Sugar pill

PLACEBO COMPARATOR

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

Interventions

varenicline DRUG

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.

Also known as: Champix (Canada), Chantix (USA)

Varenicline

placebo OTHER

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.

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mark Eisenberg: lead
• Unity Health Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator

Study Sites (4)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

SMBD - Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Related Publications (7)

• 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.

  PMID: 34611902 DERIVED

• 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.

  PMID: 29581161 DERIVED

• 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.

  PMID: 28420644 DERIVED

• 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.

  PMID: 26553744 DERIVED

• 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.

  PMID: 26386786 DERIVED

• 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.

  PMID: 24267809 DERIVED

• 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.

  PMID: 23369417 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Mark Eisenberg, MD MPH
• Organization: Jewish General Hospital / McGill University

mark.eisenberg@ladydavis.ca

5143408222

Study Officials

• Mark J Eisenberg, MD, MPH

  SMBD - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Divisions of Cardiology and Clinical Epidemiology

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: September 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 23, 2019
• Results First Posted: May 23, 2019

Record last verified: 2019-04

Locations

CA (4)