CompletedPhase 4

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease

Canada50 participantsStarted 2009-04

Plain-language summary

The purpose of this study is to determine if a new drug, varenicline, for smoking cessation is more effective than the standard nicotine replacement therapy aide currently used, "the patch" among smokers hospitalized with coronary heart disease.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * smoking at least 10 cigarettes/day in the month prior to admission * patient has been diagnosed with acute coronary syndrome (includes patients admitted for unstable angina or acute myocardial infarction), elective percutaneous coronary intervention, or coronary artery bypass surgery at any point in time * motivated to stop smoking * geographically available for follow-up visits (i.e., live within 1 hour of the study centre) Exclusion Criteria: * have been using NRT, Zyban (or Wellbutrin), and/or Champix for more than 72 hours * have serious cardiac arrhythmias (e.g., tachycardia), vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina) * have severe renal impairment or are on dialysis * unable to read and understand English * patient is pregnant or breastfeeding or planning on becoming pregnant during the study period

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome will be the self-reported continuous abstinence rate, confirmed by exhaled carbon monoxide levels of 10ppm or below during the last 4 weeks of treatment (Varenicline weeks 9-12 and NRT weeks 8-11).

Timeframe: 12 weeks

Trial details

NCT IDNCT00959972

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

View on ClinicalTrials.gov More Coronary Heart Disease trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.