Aggressive Smoking Cessation Trial (ASAP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital
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.
Eligibility criteria
Qualifiers
Ischemic symptoms for ≥ 20 min;
Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
Development of pathological Q waves on the ECG
Ischemic symptoms for ≥ 20 min;
Disqualifiers
Pregnant or lactating females;
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);
Trial design
Treatments tested in this trial
- Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)
- Varenicline Plus Counseling
Treatment groups
798 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov