NCT05257629 Aggressive Smoking Cessation Trial (ASAP)

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 798 participants in total. It began in 2023-02-02 with a primary completion date of 2026-03-07.

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 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.

Eligibility Criteria

Inclusion Criteria: 1. 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: 1. Ischemic symptoms for ≥ 20 min; 2. Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression); 3. Development of pathological Q waves on the ECG ii. Unstable angina with significant coronary artery disease, defined by all of the following: 1. Ischemic symptoms for ≥ 20 min; 2. ECG changes indicative of ischemia (ST-segment changes); 3. 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: 1. Coronary artery disease documented with angiography or coronary CT; 2. Previous ACS, MI, stable or UA; 3. 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: 1. Abdominal aortic aneurysm \> 3.0 cm or previous aortic aneurysm surgery; 2. Ankle-brachial pressure index of \< 0.9 or intermittent claudication; 3. Documented carotid artery disease; 4. Lower-limb amputation; 5. Previous lower-limb bypass surgery or angioplasty. v. ≥1 risk factors: 1. BMI ≥ 27 kg/m2; 2. Dyslipidemia; 3. Family history (first degree relative: parents or siblings only) of coronary heart disease or stroke before the age of 60 years; 4. Hypertension; 5. Males aged ≥ 55 years/females aged ≥ 60 years; 6. Diabetes mellitus. vi. Heart-related conditions: <!-- --> 1. Atrial fibrillation or flutter; 2. Cardiomyopathy; 3. Heart failure; 4. Left ventricular hypertrophy (evidenced by echocardiography or ECG); 5. Valvular disease (evidenced by echocardiography). 2. Smoked on average ≥ conventional cigarettes/day for the past year; 3. Age ≥18 years; 4. Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5); 5. Able to understand and provide informed consent in English or French; 6. 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; 7. Likely to be available for 52 weeks of follow-up. Exclusion Criteria: 1. Pregnant or lactating females; 2. 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; 3. Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment \[Note: If participant is prescribed non-study NRT while hospitalized, they can continue using the non-study NRT until being discharged, even while taking the investigational products. Upon discharge, use of the non-study NRT should be stopped.\]; 4. Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 days consecutively in the past year; 5. Previous serious adverse reaction to varenicline and/or e-cigarettes (nicotine or non-nicotine); 6. NYHA or Killip Class III or IV at the time of randomization; 7. Any unstable psychiatric disorder (as per enrolling physician); 8. Renal impairment with creatinine levels ≥2 times upper limit of normal or eGFR ≤15; 9. Use of any illegal drugs in the past year; 10. Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period. \[Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.\]

Contact & Investigator

Frequently Asked Questions

Related Trials