Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Mark Eisenberg
Collaborators:
Queen Elizabeth II Health Sciences Centre St. Michael's Hospital, Toronto Sunnybrook Health Sciences Centre Unity Health Toronto