NCT00959972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

May 28, 2026

Status Verified

April 1, 2011

Enrollment Period

1.6 years

First QC Date

August 14, 2009

Last Update Submit

May 25, 2026

Conditions

Coronary Heart Disease

Keywords

Vareniclinetransdermal nicotine patchcardiovascular diseasepreventioncoronary heart diseaseSmoking cessation

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 weeks

Secondary Outcomes (2)

  • Carbon monoxide confirmed continuous abstinence rate at weeks 24 and 52.

    9 weeks to 52 weeks

  • &-day point prevalence of abstinence confirmed by Carbon Monoxide levels

    End of treatment (12 weeks) to 52 weeks.

Study Arms (2)

Varenicline

EXPERIMENTAL

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.

Drug: Varenicline

Transdermal Nicotine Patch

EXPERIMENTAL

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.

Drug: Transdermal Nicotine Patch

Interventions

VareniclineDRUG

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.

Also known as: Champix, Chantix
Varenicline
Transdermal Nicotine PatchDRUG

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.

Also known as: Nicotine Patch, Patch, Nicoderm, NRT
Transdermal Nicotine Patch

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (8)

  • Pipe A. Smoking. Can J Cardiol. 1999 Dec;15 Suppl G:77G-80G. No abstract available.

    PMID: 10692663BACKGROUND

  • 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.

    PMID: 14583958BACKGROUND

  • 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.

    PMID: 17636688BACKGROUND

  • 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.

    PMID: 16835672BACKGROUND

  • 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.

    PMID: 15820167BACKGROUND

  • 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.

    PMID: 16820546BACKGROUND

  • 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.

    PMID: 18263663BACKGROUND

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

Coronary DiseaseCardiovascular DiseasesSmoking Cessation

Interventions

VareniclineTobacco Use Cessation DevicesTransdermal PatchNicotine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesTherapeuticsEquipment and SuppliesSolanaceous AlkaloidsAlkaloidsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Robert Reid, PhD MBA

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Andrew Pipe, MD

    Ottawa Heart Institute Research Corporation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

May 28, 2026

Record last verified: 2011-04

Locations

CA(1)