CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
varenicline +1 moredrug
Likely dose
varenicline 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00794573
NCT00794573Phase 3Completed

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

Mark Eisenberg·interventional·Posted Nov 20, 2008·Updated May 23, 2019

In Brief

A Phase 3 clinical trial evaluating varenicline and placebo for Acute Coronary Syndrome. Completed, enrolled 302 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2008
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.6 years ago

Interventions

vareniclinedrug

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.