NCT05257629.

Study name	Aggressive smoking cessation therapy post‐acute coronary syndrome (ASAP) trial
Methods	RCT Setting Hospital . Jewish General Hospital, USA
Participants	Estimated enrolment: 798 Inclusion criteria: Currently hospitalized (or at time of discharge) for ACS. Defined as follows: MI, defined by positive troponin T, troponin I, or CK‐MB levels (as defined by institution‐specific cut‐offs). For definition see NCT record. CC user; motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5); ≥ 18 years Exclusion criteria: Use of any of the following in the 30 days prior to ACS admission: i. Pharmacotherapy (e.g. NRTs, bupropion, or varenicline) for smoking cessation; ii. Nicotine or non‐nicotine e‐cigarettes; iii. Psychotropic medications (e.g. mood stabilizers, antipsychotics, prescribed opiates and sedatives); iv. Other anti‐craving medication (e.g. naltrexone, acamprosate) with the potential to alter substance‐seeking behaviours Pregnancy/breastfeeding For a full list see NCT record.
Interventions	EC: participants choice Arm 1: Combination therapy arm (varenicline and nicotine EC plus counselling)  Patients in the combination therapy arm will be supplied funds and instructions for the purchase of EC 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, we 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 EC, 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. Arm 2: Varenicline plus counselling 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.
Outcomes	1, 2, 8, 18, 24 weeks week 4, week 12, and week 52 Number of participants with: 7‐day point prevalence smoking abstinence (biochemically‐validated); continuous smoking abstinence; prolonged smoking abstinence; change in daily cigarette consumption; ≥ 50% reduction in daily cigarette consumption; point prevalent abstinence or ≥ 50% reduction in daily cigarette consumption at 24 weeks Frequency of Adverse Events (AEs) or SAEs Spirometry measurements (subset) at all other clinic visits (FVC, FEV1, and FEV1/FVC)  O2 cost diagram and COPD Assessment Test (subset) at all other clinic visits  Number of patients averaging ≥ 1 pill of varenicline/day
Starting date	Estimated start date: June 1 2022. Estimated completion date: March 7 2027
Contact information	Carole Bohbot 514‐340‐8222 ext 22790. ASAP.Trial@ladydavis.ca, carole.bohbot@ladydavis.ca
Notes	New to 2022 update