CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 392 enrolled
Drug / intervention
Bupropion HCl ER +1 moredrug
Likely dose
Bupropion HCl ER 150 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/NCT00689611
NCT00689611Phase 3Completed

Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial

Mark Eisenberg·interventional·Posted Jun 3, 2008·Updated Apr 23, 2015

In Brief

A Phase 3 clinical trial evaluating Bupropion HCl ER and Placebo for Acute Coronary Syndrome and 2 related conditions. Completed, enrolled 392 participants across 38 sites in 7 countries.

Detailed Summary

Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBangladesh, Canada, India, Iran, Pakistan, Tunisia, United States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2008
Enrollment StartDec 1, 2005
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.1 years ago

Interventions

Bupropion HCl ERdrug

150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks

Placebodrug

Placebo