Clinical Trial

Aggressive Smoking Cessation Trial (ASAP)

Study acronym: ASAP
Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated April 29, 2025 (before its estimated March 7, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2022-02-17; most recent amendment 2025-04-24.
Status change: Not Yet Recruiting → Recruiting 2022-11-01
Trial Details
NCT Number NCT05257629
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Conditions Acute Coronary Syndrome, Cardiovascular Diseases
Enrollment 798 participants
Start Date 2023-02-02
Primary Completion 2026-03-07 (estimated)
Study Completion 2027-03-07 (estimated)
Updated on ClinicalTrials.gov 2025-04-29