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Aggressive Smoking Cessation Trial (ASAP)

NCT05257629 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 798

Last updated 2025-04-29

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)

Varenicline and nicotine e-cigarettes plus counseling

OTHER

Varenicline Plus Counseling

Varenicline plus counseling

Sponsors & Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2026-03-07
Completion
2027-03-07

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257629 on ClinicalTrials.gov