Acute Coronary SyndromePhase 3ASAPNCT05257629
Aggressive Smoking Cessation Trial (ASAP)
A Phase 3 study testing Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) and Varenicline Plus Counseling in people with Acute Coronary Syndrome and Cardiovascular Diseases, run by Sir Mortimer B. Davis - Jewish General Hospital at 13 sites in Canada.
Trial summary
The ASAP Trial is a 5-year, multi-centre, randomized controlled trial that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Cardiovascular Diseases
- What is being tested?
- Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) and Varenicline Plus Counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 798 participants
- Where
- 13 sitesCanada
- Study dates
- 2 Feb 2023to 7 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows:
- MI, defined by positive troponin T, troponin I, or CK-MB levels (as defined by institution-specific cut-offs) and ≥ 1 of the following:
- Ischemic symptoms for ≥ 20 min;
- Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
- Development of pathological Q waves on the ECG
- Unstable angina with significant coronary artery disease, defined by all of the following:
Show all 42Show fewer
- Ischemic symptoms for ≥ 20 min;
- ECG changes indicative of ischemia (ST-segment changes);
- At least one lesion ≥ 50% on angiogram performed during the current hospitalization.
- [Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.]
- OR
- Outpatients with the following diagnoses/conditions:
- Cardiovascular:
- Coronary artery disease documented with angiography or coronary CT;
- Previous ACS, MI, stable or UA;
- Previous coronary revascularization (e.g. PCI or CABG). ii. Renovascular:
- Chronic kidney disease. iii. Cerebrovascular:
- Previous cerebral infarction or transient cerebral ischemic attack. iv. Peripheral vascular:
- Abdominal aortic aneurysm > 3.0 cm or previous aortic aneurysm surgery;
- Ankle-brachial pressure index of < 0.9 or intermittent claudication;
- Documented carotid artery disease;
- Lower-limb amputation;
- Previous lower-limb bypass surgery or angioplasty.
- ≥1 risk factors:
- BMI ≥ 27 kg/m2;
- Dyslipidemia;
- Family history (first degree relative: parents or siblings only) of coronary heart disease or stroke before the age of 60 years;
- Hypertension;
- Males aged ≥ 55 years/females aged ≥ 60 years;
- Diabetes mellitus. vi. Heart-related conditions:
- <!-- -->
- Atrial fibrillation or flutter;
- Cardiomyopathy;
- Heart failure;
- Left ventricular hypertrophy (evidenced by echocardiography or ECG);
- Valvular disease (evidenced by echocardiography).
- Smoked on average ≥ conventional cigarettes/day for the past year;
- Age ≥18 years;
- Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5);
- Able to understand and provide informed consent in English or French;
- If randomized to the combination arm (varenicline and e-cigarette plus counseling), willing and able to purchase e-cigarettes with the following properties: rechargeable, closed system that uses sealed cartridges or pods, tobacco or no flavor only, and nicotine strength of 20 mg/ml (2%) or less;
- Likely to be available for 52 weeks of follow-up.
Who cannot join
- Pregnant or lactating females;
- Use of any of the following in the 30 days prior to eligibility assessment:
- Varenicline or bupropion for smoking cessation; ii. Nicotine or non-nicotine e-cigarettes; iii. Other anti-craving medication (e.g., naltrexone, acamprosate) with the potential to alter substance-seeking behaviors;
- Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment [Note: If participant is prescribed non-study NRT while hospitalized, they can continue using the non-study NRT until being discharged, even while taking the investigational products. Upon discharge, use of the non-study NRT should be stopped.];
- Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 days consecutively in the past year;
- Previous serious adverse reaction to varenicline and/or e-cigarettes (nicotine or non-nicotine);
Show all 11Show fewer
- NYHA or Killip Class III or IV at the time of randomization;
- Any unstable psychiatric disorder (as per enrolling physician);
- Renal impairment with creatinine levels ≥2 times upper limit of normal or eGFR ≤15;
- Use of any illegal drugs in the past year;
- Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period. [Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.]
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Canada13 sites, 13 recruiting
- Recruiting
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
David Fillmore, david.fillmore@nshealth.ca
Jafna Cox
- Recruiting
St. Joseph's Hospital
London, Ontario
Tim Hartley, Tim.Hartley@lhsc.on.ca
Neville Suskin
- Recruiting
Dr. Georges-L.-Dumont University Hospital Center
Moncton, New Brunswick, E1C 2Z3
Melissa Daigle, melissa.daigle@vitalitenb.ca
Jean-Francois Baril
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Marie-Gabrielle Lessard, marie-gabrielle.lessard@icm-mhi.org
Jean-Francois Tanguay
- Recruiting
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, H2X 3E4
Benjamin Orcese, benjamin.orcese.chum@ssss.gouv.qc.ca
Stephane Elkouri
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Caroline Boudreault, caroline.boudreault@muhc.mcgill.ca
Thao Huynh
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Tabitha Finch, 514-340-8222, ASAP.Trial@ladydavis.ca
Mark Eisenberg
- Recruiting
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4
Anjali Menon, amenon@fraserclinicaltrials.com
Sina Alipour
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Ashley Baldwin, asbaldwin@ottawaheart.ca
Hassan Mir
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
Genevieve Pouliot, genevieve.pouliot.9@ulaval.ca
Tomas Cieza
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Rama Mangipudi, rkm352@mail.usask.ca
Jay Shavadia
- Recruiting
NL Health Sciences
St. John's, Newfoundland and Labrador, A1B 3V6
Shianne Beson, shianne.beson@nlhealthservices.ca
Mohammad Almutawa
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Ambreen Syeda, ambreen.syeda@sunnybrook.ca
Eugene Crystal
About this study
Official title: Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial
The ASAP Trial is a 5-year, multi-centre, randomized controlled trial that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. It will recruit 798 adult patients smoking on average at least 10 conventional (tobacco) cigarettes per day who are motivated to quit smoking and have either been diagnosed with ACS requiring hospitalization or are outpatients at elevated cardiovascular risk. Patients will be randomized (1:1) to one of two treatment arms: (1) combination therapy of varenicline and nicotine e-cigarettes plus counseling or (2) varenicline plus counseling for 12 weeks, with 52-week follow-up.
Read the detailed description
Background and Importance:
People who smoke are at an elevated risk of developing cardiovascular disease (CVD). Those who have an acute coronary syndrome (ACS), including myocardial infarction and unstable angina, and continue to smoke have a 35% increased risk of reinfarction or death compared with those who quit. Our previous smoking cessation trials have established varenicline (Champix) as the "gold standard" for patients with CVD. However, more than 50% of patients motivated to quit who receive varenicline for 12 weeks immediately post-ACS will return to smoking within 6 months. Therefore, more effective smoking cessation strategies are needed. Based on newly available data from randomized controlled trials (RCTs), including our E3 Trial, which suggest that nicotine e-cigarettes are more efficacious for smoking cessation than other nicotine replacement therapies and counseling alone, the investigators propose to combine varenicline and nicotine e-cigarettes (aggressive smoking cessation therapy). The proposed aggressive therapy is a novel approach needed now to increase abstinence in people at elevated cardiovascular risk.
Goal(s)/Research Aims:
The Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial is a 5-year, multi-centre RCT that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. The specific aims are:
- To assess the efficacy of combination therapy (varenicline and nicotine e-cigarettes) versus varenicline alone for 12 weeks, in terms of biochemically-validated 7-day point prevalence and continuous smoking abstinence, and ≥50% reduction in daily cigarette consumption at 24 and 52 weeks among people at elevated cardiovascular risk.
- To describe the safety and tolerability of varenicline combined with nicotine e-cigarettes, in terms of serious adverse events (SAEs), adverse events (AEs), treatment discontinuation due to side effects, and therapy adherence over the 12-week treatment period.
Methods/Approaches/Expertise:
A total of 798 participants will be randomized 1:1 to: (1) varenicline and nicotine e-cigarettes (aggressive smoking cessation therapy), or (2) varenicline alone for 12 weeks, with follow-up of 52 weeks. Both arms will receive individual smoking cessation counseling. Participants randomized to aggressive therapy (varenicline and nicotine e-cigarette) will be given funds to cover the purchase of e-cigarettes and nicotine cartridges. Funds will be provided at baseline for the first 4 weeks of e-cigarette use. Participants who follow the e-cigarette purchasing instructions and provide receipts at subsequent clinic visits will be provided additional funds at week 4 (for weeks 4 to 8) and reimbursed at week 12 (for weeks 8 to 12). Participants will begin varenicline (titrated to 1.0 mg twice daily) and counseling at baseline, and e-cigarette use (if applicable) after the baseline visit. Eligible people will have or be at elevated risk of developing CVD, self-identify as regular smokers (≥10 cigarettes/day for ≥1 year), and be motivated to quit. They will complete telephone follow-ups at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52. We will collect information about self-reported smoking, treatment adherence, and adverse events. Self-reported smoking abstinence will be biochemically-validated at clinic visits using exhaled carbon monoxide (≤10 ppm). The primary endpoint will be biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks. With 399 participants per arm and an alpha of .05, the investigators will have 80% power to detect a ≥10% difference in abstinence at 24 weeks. The ASAP Trial will be conducted by a highly experienced team of researchers and enrolling centres, who have previously completed three smoking cessation RCTs, including two in cardiac patients.
Expected Outcomes:
Smoking cessation is essential to reduce morbidity and mortality in this high-risk patient population. ASAP will provide regulators, health care professionals, and smokers with important information about the efficacy of aggressive varenicline and nicotine e-cigarettes therapy for smoking cessation in people at an elevated cardiovascular risk.
- Conditions
- Acute Coronary Syndrome, Cardiovascular Diseases
- Being tested
- Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling), Varenicline Plus Counseling
- Keywords
- acute coronary syndrome, smoking cessation, randomized controlled trial, varenicline, e-cigarettes, cardiovascular disease
- Medical subject headings
- Acute Coronary Syndrome, Cardiovascular Diseases, Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)Combination product
Varenicline and nicotine e-cigarettes plus counseling
Varenicline Plus CounselingOther
Varenicline plus counseling
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) | Active comparator | Patients in the combination therapy arm will be supplied funds and instructions for the purchase of e-cigarettes and cartridges/pods upon hospital discharge and at the week 4 and 12 clinic visits. As with standard NRTs such as the gum, inhaler, and lozenge, the investigators expect smokers will self-regulate administration according to their withdrawal symptoms. Use will be monitored via self-report for telephone follow-ups. At clinic visits, patients will be asked to bring their e-cigarettes, used and unused cartridges/pods, and purchasing receipts. Patients will be advised regarding the signs and symptoms of nicotine toxicity and of an allergic reaction. Receives: Combination Product: Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) |
| Varenicline Plus Counseling | Other | All patients will begin varenicline in-hospital upon randomization. For the first 3 days, patients will take a 0.5 mg tablet once a day. They will then take a 0.5 mg tablet twice a day for the following 4 days, and one 1 mg tablet twice a day from day 8 onward for the remainder of the 12-week treatment. Use will be monitored via self-report for telephone follow-ups and return of all unused tablets at the end of the treatment period. Should a patient experience severe side effects (such as headache, nausea, vomiting, dizziness, dyspepsia, fatigue, insomnia, abnormal dreams, constipation, or flatulence) on day 8 onward, the varenicline dose should be reduced from 1 mg twice daily to 0.5 mg twice daily prior to study medication discontinuation. Receives: Other: Varenicline Plus Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 7-day point prevalence smoking abstinence
Biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm.
Measured: 24 weeks
Secondary outcomes (10)
Number of participants with continuous smoking abstinence
Biochemically-validated continuous abstinence at 4, 12, and 24 weeks, defined as self-reported abstinence since baseline with exhaled carbon monoxide ≤ 10 ppm at all clinic follow-ups, and self-reported 0 cigarette smoked in the past 7 days at telephone follow-ups (1, 2, 8, and 18 weeks).
Measured: 1, 2, 8, and 18 weeks
Number of participants with prolonged smoking abstinence
Prolonged abstinence, defined as self-reported abstinence at all clinical and telephone follow-ups after an initial 2-week grace period with exhaled carbon monoxide ≤ 10 ppm at 4, 12, and 24 weeks, and self-reported 0 cigarette smoked in the past 7 days at the 8, and 18 weeks telephone follow-ups.
Measured: 4, 8, 12, 18, and 24 weeks
Change in daily cigarette consumption
Change in self-reported daily conventional cigarette consumption from baseline compared to 24 weeks.
Measured: 24 weeks
Number of participants with ≥50% reduction in daily cigarette consumption
Proportion of participants with ≥50% reduction in self-reported daily cigarette consumption from baseline compared to 24-weeks.
Measured: 24 weeks
Number of participants with point prevalent abstinence or ≥50% reduction in daily cigarette consumption at 24 weeks
Composite endpoint of point prevalent abstinence or ≥50% reduction in daily cigarette consumption at 24 weeks
Measured: 24 weeks
Frequency of Serious Adverse Events (SAEs)
The number of serious adverse events (SAE) reported over the 12 week treatment period.
A SAE is defined as an adverse event which requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life-threatening, or that results in death.
Measured: 12 weeks
Frequency of Adverse Events (AEs)
The number of adverse events reported over the 12 week treatment period. An adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the trial drug, whether or not considered related to the e-cigarettes or varenicline.
Measured: 12 weeks
Frequency of drop-outs
The number of drop-outs due to side effects of the e-cigarettes or varenicline over the 12 week treatment period.
Measured: 12 weeks
Spirometry measurements (subset)
For a sub-set of 100 patients, 50 from each arm, randomized at 4-5 recruiting sites, undergoing spirometry measurements, differences in FVC, FEV1, and FEV1/FVC ratio as well as measures of small airways disease between pre- and post-bronchodilator at week 24 from baseline.
Measured: 24 weeks
O2 Cost Diagram and COPD Assessment Test (subset)
For the same sub-set of 100 patients undergoing spirometry measurements randomized at 4-5 recruiting sites, the difference in the O2 Cost Diagram and the CAT at week 24 from baseline.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start2 Feb 2023
- Primary completion7 Mar 2026 (estimated)
- Study completion7 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 798 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Eisenberg, MD, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257629
- Sponsor's protocol ID
- ASAP-001, Version 10
- Acronym
- ASAP
- Status last verified
- Apr 2025
- First submitted
- 1 Feb 2022
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial
- ClinicalTrials.gov ID
- NCT05257629
- Acronym / sponsor ID
- ASAP / ASAP-001, Version 10
- Conditions
- Acute Coronary Syndrome, Cardiovascular Diseases
- Keywords
- acute coronary syndrome, smoking cessation, randomized controlled trial, varenicline, e-cigarettes, cardiovascular disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 798 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 7 Mar 2026 (estimated)
- Study completion
- 7 Mar 2027 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ASAP Trial is a 5-year, multi-centre, randomized controlled trial that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. It will recruit 798 adult patients smoking on average at least 10 conventional (tobacco) cigarettes per day who are motivated to quit smoking and have either been diagnosed with ACS requiring hospitalization or are outpatients at elevated cardiovascular risk. Patients will be randomized (1:1) to one of two treatment arms: (1) combination therapy of varenicline and nicotine e-cigarettes plus counseling or (2) varenicline plus counseling for 12 weeks, with 52-week follow-up.
Detailed description
Background and Importance:
People who smoke are at an elevated risk of developing cardiovascular disease (CVD). Those who have an acute coronary syndrome (ACS), including myocardial infarction and unstable angina, and continue to smoke have a 35% increased risk of reinfarction or death compared with those who quit. Our previous smoking cessation trials have established varenicline (Champix) as the "gold standard" for patients with CVD. However, more than 50% of patients motivated to quit who receive varenicline for 12 weeks immediately post-ACS will return to smoking within 6 months. Therefore, more effective smoking cessation strategies are needed. Based on newly available data from randomized controlled trials (RCTs), including our E3 Trial, which suggest that nicotine e-cigarettes are more efficacious for smoking cessation than other nicotine replacement therapies and counseling alone, the investigators propose to combine varenicline and nicotine e-cigarettes (aggressive smoking cessation therapy). The proposed aggressive therapy is a novel approach needed now to increase abstinence in people at elevated cardiovascular risk.
Goal(s)/Research Aims:
The Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial is a 5-year, multi-centre RCT that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. The specific aims are:
- To assess the efficacy of combination therapy (varenicline and nicotine e-cigarettes) versus varenicline alone for 12 weeks, in terms of biochemically-validated 7-day point prevalence and continuous smoking abstinence, and ≥50% reduction in daily cigarette consumption at 24 and 52 weeks among people at elevated cardiovascular risk.
- To describe the safety and tolerability of varenicline combined with nicotine e-cigarettes, in terms of serious adverse events (SAEs), adverse events (AEs), treatment discontinuation due to side effects, and therapy adherence over the 12-week treatment period.
Methods/Approaches/Expertise:
A total of 798 participants will be randomized 1:1 to: (1) varenicline and nicotine e-cigarettes (aggressive smoking cessation therapy), or (2) varenicline alone for 12 weeks, with follow-up of 52 weeks. Both arms will receive individual smoking cessation counseling. Participants randomized to aggressive therapy (varenicline and nicotine e-cigarette) will be given funds to cover the purchase of e-cigarettes and nicotine cartridges. Funds will be provided at baseline for the first 4 weeks of e-cigarette use. Participants who follow the e-cigarette purchasing instructions and provide receipts at subsequent clinic visits will be provided additional funds at week 4 (for weeks 4 to 8) and reimbursed at week 12 (for weeks 8 to 12). Participants will begin varenicline (titrated to 1.0 mg twice daily) and counseling at baseline, and e-cigarette use (if applicable) after the baseline visit. Eligible people will have or be at elevated risk of developing CVD, self-identify as regular smokers (≥10 cigarettes/day for ≥1 year), and be motivated to quit. They will complete telephone follow-ups at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52. We will collect information about self-reported smoking, treatment adherence, and adverse events. Self-reported smoking abstinence will be biochemically-validated at clinic visits using exhaled carbon monoxide (≤10 ppm). The primary endpoint will be biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks. With 399 participants per arm and an alpha of .05, the investigators will have 80% power to detect a ≥10% difference in abstinence at 24 weeks. The ASAP Trial will be conducted by a highly experienced team of researchers and enrolling centres, who have previously completed three smoking cessation RCTs, including two in cardiac patients.
Expected Outcomes:
Smoking cessation is essential to reduce morbidity and mortality in this high-risk patient population. ASAP will provide regulators, health care professionals, and smokers with important information about the efficacy of aggressive varenicline and nicotine e-cigarettes therapy for smoking cessation in people at an elevated cardiovascular risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) | Active comparator | Combination Product: Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)Patients in the combination therapy arm will be supplied funds and instructions for the purchase of e-cigarettes and cartridges/pods upon hospital discharge and at the week 4 and 12 clinic visits. As with standard NRTs such as the gum, inhaler, and lozenge, the investigators expect smokers will self-regulate administration according to their withdrawal symptoms. Use will be monitored via self-report for telephone follow-ups. At clinic visits, patients will be asked to bring their e-cigarettes, used and unused cartridges/pods, and purchasing receipts. Patients will be advised regarding the signs and symptoms of nicotine toxicity and of an allergic reaction. |
| Varenicline Plus Counseling | Other | Other: Varenicline Plus CounselingAll patients will begin varenicline in-hospital upon randomization. For the first 3 days, patients will take a 0.5 mg tablet once a day. They will then take a 0.5 mg tablet twice a day for the following 4 days, and one 1 mg tablet twice a day from day 8 onward for the remainder of the 12-week treatment. Use will be monitored via self-report for telephone follow-ups and return of all unused tablets at the end of the treatment period. Should a patient experience severe side effects (such as headache, nausea, vomiting, dizziness, dyspepsia, fatigue, insomnia, abnormal dreams, constipation, or flatulence) on day 8 onward, the varenicline dose should be reduced from 1 mg twice daily to 0.5 mg twice daily prior to study medication discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows:
- [Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.]
- OR
- <!-- -->
- Smoked on average ≥ conventional cigarettes/day for the past year;
Key exclusion criteria (11 listed)
- Pregnant or lactating females;
- Use of any of the following in the 30 days prior to eligibility assessment:
- Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment [Note: If participant is prescribed non-study NRT while hospitalized, they can continue using the non-study NRT until being discharged, even while taking the investigational products. Upon discharge, use of the non-study NRT should be stopped.];
- Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 days consecutively in the past year;
- Previous serious adverse reaction to varenicline and/or e-cigarettes (nicotine or non-nicotine);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)Varenicline and nicotine e-cigarettes plus counseling | Combination product | Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) |
| Varenicline Plus CounselingVarenicline plus counseling | Other | Varenicline Plus Counseling |
Primary outcome
Number of participants with 7-day point prevalence smoking abstinence
Time frame: 24 weeks
Biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm.
10 secondary outcomes
Number of participants with continuous smoking abstinence
Time frame: 1, 2, 8, and 18 weeks
Number of participants with prolonged smoking abstinence
Time frame: 4, 8, 12, 18, and 24 weeks
Change in daily cigarette consumption
Time frame: 24 weeks
Number of participants with ≥50% reduction in daily cigarette consumption
Time frame: 24 weeks
Number of participants with point prevalent abstinence or ≥50% reduction in daily cigarette consumption at 24 weeks
Time frame: 24 weeks
Frequency of Serious Adverse Events (SAEs)
Time frame: 12 weeks
Frequency of Adverse Events (AEs)
Time frame: 12 weeks
Frequency of drop-outs
Time frame: 12 weeks
Spirometry measurements (subset)
Time frame: 24 weeks
O2 Cost Diagram and COPD Assessment Test (subset)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) and Varenicline Plus Counseling in people with Acute Coronary Syndrome and Cardiovascular Diseases, run by Sir Mortimer B. Davis - Jewish General Hospital at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 42 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tabitha Finch (514-340-8222 ext. 23240, ASAP.Trial@ladydavis.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with 7-day point prevalence smoking abstinence (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.