Status:
COMPLETED
Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial
Lead Sponsor:
Mark Eisenberg
Collaborating Sponsors:
Unity Health Toronto
Sunnybrook Health Sciences Centre
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00794573
Start Date
September 1 2009
End Date
December 1 2015
Last Update
May 23 2019
Active Locations (4)
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1
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
3
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
4
SMBD - Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2