Comparing Combination Therapy Arm (Varenicline with Varenicline Plus Counseling for acute coronary syndrome
Official title: Aggressive Smoking Cessation Trial (ASAP)
Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial
Interventions
Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)
Varenicline and nicotine e-cigarettes plus counseling
Varenicline Plus Counseling
Varenicline plus counseling
Canadian Sites (13)
Fraser Clinical Trials
New Westminster, British Columbia, Canada
Dr. Georges-L.-Dumont University Hospital Center
Moncton, New Brunswick, Canada
NL Health Sciences
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
St. Joseph's Hospital
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for51 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years;
- +Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows:
- +i. 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
- +ii. Unstable angina with significant coronary artery disease, defined by all of the following:
- +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.
- +Outpatients with the following diagnoses/conditions:
- +i. 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:
- +a. Chronic kidney disease. iii. Cerebrovascular:
- +a. Previous cerebral infarction or transient cerebral ischemic attack. iv. Peripheral vascular:
- +Ankle-brachial pressure index of \< 0.9 or intermittent claudication;
- +Documented carotid artery disease;
- +Lower-limb amputation;
- +v. ≥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).
- +Able to understand and provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in English or French;
- +Likely to be available for 52 weeks of follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
- +\[Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.\]
- +Abdominal aortic aneurysm \> 3.0 cm or previous aortic aneurysm surgery;
- +Previous lower-limb bypass surgery or angioplasty.
- +Smoked on average ≥ conventional cigarettes/day for the past year;
- +Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5);
- +If randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to the combination armArmOne of the groups in a study, each receiving something different.Read more → (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;
Exclusion
- −Use of any of the following in the 30 days prior to eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → assessment:
- −NYHA or Killip Class III or IV at the time of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →;
- −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;
- −Pregnant or lactating females;
- −i. 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 reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → to varenicline and/or e-cigarettes (nicotine or non-nicotine);
- −Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period. \[Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.\]
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Combination Therapy ArmArmOne of the groups in a study, each receiving something different.Read more → (Varenicline and Nicotine E-Cigarettes Plus Counseling), Varenicline Plus Counseling.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 798 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: 24 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with 7-day point prevalence smoking abstinence — measured over 24 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05257629 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)Combination product
Varenicline and nicotine e-cigarettes plus counseling
From the trial registry — its own words, unedited.
What a combination product is here: A product that combines two categories — for example a drug delivered by a device.
Read the full explanation → · in clinical review
About Varenicline Plus CounselingOther
Varenicline plus counseling
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 24 weeks.
The study as a whole is currently expected to finish around 2027-03-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 798 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: New Westminster, British Columbia, Canada; Moncton, New Brunswick, Canada; St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.