Status:
RECRUITING
Aggressive Smoking Cessation Trial (ASAP)
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Acute Coronary Syndrome
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 cardiovas...
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 un...
Eligibility Criteria
Inclusion
- 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.
- \[Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.\]
- OR
- Outpatients with the following diagnoses/conditions:
- 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:
- 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.
- 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:
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- 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.
Exclusion
- Pregnant or lactating females;
- Use of any of the following in the 30 days prior to eligibility assessment:
- 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 reaction to varenicline and/or e-cigarettes (nicotine or non-nicotine);
- 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. \[Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.\]
Key Trial Info
Start Date :
February 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2027
Estimated Enrollment :
798 Patients enrolled
Trial Details
Trial ID
NCT05257629
Start Date
February 2 2023
End Date
March 7 2027
Last Update
April 29 2025
Active Locations (13)
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1
Fraser Clinical Trials
New Westminster, British Columbia, Canada, V3L 3W4
2
Dr. Georges-L.-Dumont University Hospital Center
Moncton, New Brunswick, Canada, E1C 2Z3
3
NL Health Sciences
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
4
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7