Phase 3 Heart Disease Trial, Recruiting NCT05257629 Sponsor: Sir Mortimer B. Davis - Jewish General Hospital Condition: Heart Disease
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Phase 3 Heart Disease Trial, Recruiting

NCT05257629
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are currently in hospital, being discharged, or are outpatients who have had a recent heart attack or unstable chest pain (angina) meeting specific medical criteria, OR outpatients who have a diagnosis related to heart and blood vessel disease, kidney disease, stroke or mini-stroke, circulation problems in the legs or arteries, certain heart conditions (such as irregular heartbeat, heart failure, or valve disease), or at least one risk factor such as high blood pressure, diabetes, high cholesterol, obesity (BMI of 27 or above), a family history of heart disease or stroke before age 60, or being a male aged 55 or older or female aged 60 or older
  • People who have smoked an average of at least a certain number of cigarettes per day (confirm exact number with trial site, as the source appears incomplete) over the past year
  • People aged 18 years or older
  • People who are strongly motivated to quit smoking, as measured by a specific motivation scale (scoring level 5 or above)
  • People who are able to understand and give informed consent in English or French
  • People who, if placed in the combination treatment group, are willing and able to purchase a specific type of e-cigarette: rechargeable, closed system with sealed cartridges or pods, tobacco flavour or no flavour only, and nicotine strength of 20 mg/ml (2%) or less
  • People who are likely to be available for follow-up appointments over 52 weeks

Who may not be able to join:

  • People who are pregnant or breastfeeding
  • People who have used varenicline or bupropion (medicines to help quit smoking), any type of e-cigarette (with or without nicotine), or certain anti-craving medications in the 30 days before being assessed for the trial
  • People who have used nicotine replacement therapy (such as patches, gum, or lozenges) in the 7 days before being assessed for the trial
  • People who have used varenicline or e-cigarettes (with or without nicotine) for 14 or more days in a row at any point in the past year
  • People who have previously had a serious bad reaction to varenicline or e-cigarettes
  • People whose heart failure is rated at a severe level (NYHA or Killip Class III or IV) at the time of joining the trial (confirm with trial site)
  • People with any unstable mental health condition, as determined by the enrolling doctor
  • People with significant kidney problems, specifically creatinine levels at twice or more the normal upper limit, or a kidney function score (eGFR) of 15 or below
  • People who have used any illegal drugs in the past year
  • People who plan to smoke cannabis or use any other smoked or smokeless tobacco products during the study period (note: non-smoked cannabis products such as edibles or oils are permitted)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 514-340-8222

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Registry
ClinicalTrials.gov
Start date
2 February 2023
Est. completion
7 March 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Number of participants with 7-day point prevalence smoking abstinence

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov