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Aggressive Smoking Cessation Trial (ASAP)

Study acronym: ASAP
StatusRecruiting
PhasePhase 3
Started
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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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 7, 2025 to Mar 7, 2026
    • Study sites: 12 to 13
    v13
  2. Study sites: 11 to 12v12
  3. Study sites: 10 to 11v11
  4. Site details revised at 10 of 10 sitesv10
  5. Secondary endpoints: details revised at 1 of 10 entries
    • Site contacts updated at 1 of 10 sites
    • Study description expanded, about 2 words
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 194 words
    • Study description expanded, about 36 words
    v8
  2. Study sites: 5 to 10v7
  3. Study sites: 4 to 5
    • Eligibility criteria shortened, about 11 words
    v6
  4. Study sites: 3 to 4v5
  5. Start date changed from estimate of Oct 31, 2022 to Feb 2, 2023
    • Study sites: 1 to 3
    • Eligibility criteria expanded, about 1 word
    v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2022 to Oct 31, 2022
    • Study sites: 0 to 1
    v3
  7. Start date: Mar 7, 2022 to Jun 1, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05257629
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Conditions
(from sponsor)		 Acute Coronary Syndrome, Cardiovascular Diseases
Related terms Acute Coronary Syndrome, Cardiovascular Diseases, Smoking Cessation, Vaping
Enrollment 798 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov