Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Varenicline
Transdermal Nicotine Patch
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease focused on measuring Varenicline, transdermal nicotine patch, cardiovascular disease, prevention, coronary heart disease, Smoking cessation
Eligibility Criteria
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
Sites / Locations
- University of Ottawa Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Varenicline
Transdermal Nicotine Patch
Arm Description
Participants randomized to varenicline will be administered 0.5 mg/day for 3 days, 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for an additional 11 weeks.
Participants randomized to NRT will apply the patch immediately on the first day and each morning thereafter for 12 weeks. Doses of NRT will be 21 mg/day for the first 6 weeks, 14 mg/day for 4 weeks, then 7 mg/day for 2 weeks.
Outcomes
Primary Outcome Measures
The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26.
Secondary Outcome Measures
Secondary outcomes will include adherence to prescribed pharmacotherapy measured at 12 weeks and measures of nicotine withdrawal and self-efficacy.
Full Information
NCT ID
NCT00959972
First Posted
August 14, 2009
Last Updated
April 27, 2011
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT00959972
Brief Title
Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease
Official Title
Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease: a Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Ontario
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Quitting smoking is the single most effective intervention or treatment to reduce death rates in patients with coronary heart disease (CHD) who smoke. At the University of Ottawa Heart Institute (Ottawa, Canada), an institutional program is in place to ensure that staff consistently identify and document tobacco use status and treatment is offered to every smoker admitted to the Institute. Currently, nicotine replacement therapy (NRT) is the principal medication used in the program. Recently, a new medication, varenicline, was approved for smoking cessation in Canada. Varenicline appears be the most effective medication for cessation currently available. To date, most published studies of varenicline have been funded by the manufacturer and there are no published studies reporting how well it works in smokers hospitalized with heart disease.
This study involves sixty current smokers hospitalized at the UOHI for CHD. Consenting smokers will be randomly assigned to receive varenicline for 12 weeks or transdermal NRT for 12 weeks. Participants will also complete a two-page questionnaire inquiring about smoking history and previous attempts to quit, level of nicotine dependence, symptoms of nicotine withdrawal and self-efficacy with respect to quitting smoking. All participants will receive identical in-hospital counseling, self-help materials and follow-up support. The nurse specialists will also contact the participants by phone 3, 14, 30 and 50 days post-hospital discharge to check the patient's smoking status, assess the risk of relapse, and identify any adverse events that have occurred. The study will follow up with participants at 12 and 26 weeks post randomization asking about their smoking status (biochemically confirmed with a carbon monoxide monitor), adherence to prescribed medication, self-efficacy with respect to quitting smoking, nicotine withdrawal and smoking cessation resources used post-discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Varenicline, transdermal nicotine patch, cardiovascular disease, prevention, coronary heart disease, Smoking cessation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varenicline
Arm Type
Experimental
Arm Description
Participants randomized to varenicline will be administered 0.5 mg/day for 3 days, 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for an additional 11 weeks.
Arm Title
Transdermal Nicotine Patch
Arm Type
Experimental
Arm Description
Participants randomized to NRT will apply the patch immediately on the first day and each morning thereafter for 12 weeks. Doses of NRT will be 21 mg/day for the first 6 weeks, 14 mg/day for 4 weeks, then 7 mg/day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Champix, Chantix
Intervention Description
Participants randomized to varenicline will be administered 0.5 mg/day for 3 days, 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for an additional 11 weeks.
Intervention Type
Drug
Intervention Name(s)
Transdermal Nicotine Patch
Other Intervention Name(s)
Nicotine Patch, Patch, Nicoderm, NRT
Intervention Description
Participants randomized to NRT will apply the patch immediately on the first day and each morning thereafter for 12 weeks. Doses of NRT will be 21 mg/day for the first 6 weeks, 14 mg/day for 4 weeks, then 7 mg/day for 2 weeks.
Primary Outcome Measure Information:
Title
The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Secondary outcomes will include adherence to prescribed pharmacotherapy measured at 12 weeks and measures of nicotine withdrawal and self-efficacy.
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Reid, PhD MBA
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Pipe, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
10692663
Citation
Pipe A. Smoking. Can J Cardiol. 1999 Dec;15 Suppl G:77G-80G. No abstract available.
Results Reference
background
PubMed Identifier
14583958
Citation
Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst Rev. 2003;(4):CD003041. doi: 10.1002/14651858.CD003041.
Results Reference
background
PubMed Identifier
17636688
Citation
Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. doi: 10.1002/14651858.CD001837.pub2.
Results Reference
background
PubMed Identifier
16835672
Citation
Reid RD, Pipe AL, Quinlan B. Promoting smoking cessation during hospitalization for coronary artery disease. Can J Cardiol. 2006 Jul;22(9):775-80. doi: 10.1016/s0828-282x(06)70294-x.
Results Reference
background
PubMed Identifier
15820167
Citation
Meine TJ, Patel MR, Washam JB, Pappas PA, Jollis JG. Safety and effectiveness of transdermal nicotine patch in smokers admitted with acute coronary syndromes. Am J Cardiol. 2005 Apr 15;95(8):976-8. doi: 10.1016/j.amjcard.2004.12.039.
Results Reference
background
PubMed Identifier
16820546
Citation
Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.
Results Reference
background
PubMed Identifier
18263663
Citation
Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.
Results Reference
background
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Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease
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