Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05257629
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2022-02-01
Brief Title:
Aggressive Smoking Cessation Trial ASAP
Sponsor:
Sir Mortimer B Davis - Jewish General Hospital
Organization:
Sir Mortimer B Davis - Jewish General Hospital
Study Overview
Official Title:
Aggressive Smoking Cessation Therapy Among People At Elevated Cardiovascular Risk ASAP Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASAP
Brief 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 11 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
Detailed Description:
Background and Importance
People who smoke are at an elevated risk of developing cardiovascular disease CVD Those who have an acute coronary syndrome ACS including myocardial infarction and unstable angina and continue to smoke have a 35 increased risk of reinfarction or death compared with those who quit Our previous smoking cessation trials have established varenicline Champix as the gold standard for patients with CVD However more than 50 of patients motivated to quit who receive varenicline for 12 weeks immediately post-ACS will return to smoking within 6 months Therefore more effective smoking cessation strategies are needed Based on newly available data from randomized controlled trials RCTs including our E3 Trial which suggest that nicotine e-cigarettes are more efficacious for smoking cessation than other nicotine replacement therapies and counseling alone the investigators propose to combine varenicline and nicotine e-cigarettes aggressive smoking cessation therapy The proposed aggressive therapy is a novel approach needed now to increase abstinence in people at elevated cardiovascular risk
GoalsResearch Aims
The Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk ASAP Trial is a 5-year multi-centre RCT that will assess the efficacy safety and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk The specific aims are
1 To assess the efficacy of combination therapy varenicline and nicotine e-cigarettes versus varenicline alone for 12 weeks in terms of biochemically-validated 7-day point prevalence and continuous smoking abstinence and 50 reduction in daily cigarette consumption at 24 and 52 weeks among people at elevated cardiovascular risk
2 To describe the safety and tolerability of varenicline combined with nicotine e-cigarettes in terms of serious adverse events SAEs adverse events AEs treatment discontinuation due to side effects and therapy adherence over the 12-week treatment period
MethodsApproachesExpertise
A total of 798 participants will be randomized 11 to 1 varenicline and nicotine e-cigarettes aggressive smoking cessation therapy or 2 varenicline alone for 12 weeks with follow-up of 52 weeks Both arms will receive individual smoking cessation counseling Participants randomized to aggressive therapy varenicline and nicotine e-cigarette will be given funds to cover the purchase of e-cigarettes and nicotine cartridges Funds will be provided at baseline for the first 4 weeks of e-cigarette use Participants who follow the e-cigarette purchasing instructions and provide receipts at subsequent clinic visits will be provided additional funds at week 4 for weeks 4 to 8 and reimbursed at week 12 for weeks 8 to 12 Participants will begin varenicline titrated to 10 mg twice daily and counseling at baseline and e-cigarette use if applicable after the baseline visit Eligible people will have or be at elevated risk of developing CVD self-identify as regular smokers 10 cigarettesday for 1 year and be motivated to quit They will complete telephone follow-ups at weeks 1 2 8 and 18 and clinic visits at weeks 4 12 24 and 52 We will collect information about self-reported smoking treatment adherence and adverse events Self-reported smoking abstinence will be biochemically-validated at clinic visits using exhaled carbon monoxide 10 ppm The primary endpoint will be biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks With 399 participants per arm and an alpha of 05 the investigators will have 80 power to detect a 10 difference in abstinence at 24 weeks The ASAP Trial will be conducted by a highly experienced team of researchers and enrolling centres who have previously completed three smoking cessation RCTs including two in cardiac patients
Expected Outcomes
Smoking cessation is essential to reduce morbidity and mortality in this high-risk patient population ASAP will provide regulators health care professionals and smokers with important information about the efficacy of aggressive varenicline and nicotine e-cigarettes therapy for smoking cessation in people at an elevated cardiovascular risk
People who smoke are at an elevated risk of developing cardiovascular disease CVD Those who have an acute coronary syndrome ACS including myocardial infarction and unstable angina and continue to smoke have a 35 increased risk of reinfarction or death compared with those who quit Our previous smoking cessation trials have established varenicline Champix as the gold standard for patients with CVD However more than 50 of patients motivated to quit who receive varenicline for 12 weeks immediately post-ACS will return to smoking within 6 months Therefore more effective smoking cessation strategies are needed Based on newly available data from randomized controlled trials RCTs including our E3 Trial which suggest that nicotine e-cigarettes are more efficacious for smoking cessation than other nicotine replacement therapies and counseling alone the investigators propose to combine varenicline and nicotine e-cigarettes aggressive smoking cessation therapy The proposed aggressive therapy is a novel approach needed now to increase abstinence in people at elevated cardiovascular risk
GoalsResearch Aims
The Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk ASAP Trial is a 5-year multi-centre RCT that will assess the efficacy safety and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk The specific aims are
1 To assess the efficacy of combination therapy varenicline and nicotine e-cigarettes versus varenicline alone for 12 weeks in terms of biochemically-validated 7-day point prevalence and continuous smoking abstinence and 50 reduction in daily cigarette consumption at 24 and 52 weeks among people at elevated cardiovascular risk
2 To describe the safety and tolerability of varenicline combined with nicotine e-cigarettes in terms of serious adverse events SAEs adverse events AEs treatment discontinuation due to side effects and therapy adherence over the 12-week treatment period
MethodsApproachesExpertise
A total of 798 participants will be randomized 11 to 1 varenicline and nicotine e-cigarettes aggressive smoking cessation therapy or 2 varenicline alone for 12 weeks with follow-up of 52 weeks Both arms will receive individual smoking cessation counseling Participants randomized to aggressive therapy varenicline and nicotine e-cigarette will be given funds to cover the purchase of e-cigarettes and nicotine cartridges Funds will be provided at baseline for the first 4 weeks of e-cigarette use Participants who follow the e-cigarette purchasing instructions and provide receipts at subsequent clinic visits will be provided additional funds at week 4 for weeks 4 to 8 and reimbursed at week 12 for weeks 8 to 12 Participants will begin varenicline titrated to 10 mg twice daily and counseling at baseline and e-cigarette use if applicable after the baseline visit Eligible people will have or be at elevated risk of developing CVD self-identify as regular smokers 10 cigarettesday for 1 year and be motivated to quit They will complete telephone follow-ups at weeks 1 2 8 and 18 and clinic visits at weeks 4 12 24 and 52 We will collect information about self-reported smoking treatment adherence and adverse events Self-reported smoking abstinence will be biochemically-validated at clinic visits using exhaled carbon monoxide 10 ppm The primary endpoint will be biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks With 399 participants per arm and an alpha of 05 the investigators will have 80 power to detect a 10 difference in abstinence at 24 weeks The ASAP Trial will be conducted by a highly experienced team of researchers and enrolling centres who have previously completed three smoking cessation RCTs including two in cardiac patients
Expected Outcomes
Smoking cessation is essential to reduce morbidity and mortality in this high-risk patient population ASAP will provide regulators health care professionals and smokers with important information about the efficacy of aggressive varenicline and nicotine e-cigarettes therapy for smoking cessation in people at an elevated cardiovascular risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None