Aggressive Smoking Cessation Trial (ASAP)

NCT05257629 | Recruiting Phase 3 DMC

• 1 other identifier: ASAP-001, Version 10
• Study Type: interventional
• Target: 798
• Locations: 1 country
• Sites: 13

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 (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

Acute Coronary Syndrome; Cardiovascular Diseases

Keywords

acute coronary syndrome; smoking cessation; randomized controlled trial; varenicline; e-cigarettes; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with 7-day point prevalence smoking abstinence

  Biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm.

  24 weeks

Secondary Outcomes (10)

• Number of participants with continuous smoking abstinence

  1, 2, 8, and 18 weeks

• Number of participants with prolonged smoking abstinence

  4, 8, 12, 18, and 24 weeks

• Change in daily cigarette consumption

  24 weeks

• Number of participants with ≥50% reduction in daily cigarette consumption

  24 weeks

• Number of participants with point prevalent abstinence or ≥50% reduction in daily cigarette consumption at 24 weeks

  24 weeks

Other Outcomes (10)

• Number of patients with 7-day point prevalence smoking abstinence at 4, 12, and 52 weeks

  4, 12, and 52 weeks

• Number of patients with continuous abstinence at 4, 12, 24, and 52 weeks

  4, 12, 24, and 52 weeks

• Number of prolonged smoking abstinence at all follow-up visits

  4, 12, 24, and 52 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

Patients in the combination therapy arm will be supplied funds and instructions for the purchase of e-cigarettes and cartridges/pods upon hospital discharge and at the week 4 and 12 clinic visits. As with standard NRTs such as the gum, inhaler, and lozenge, the investigators expect smokers will self-regulate administration according to their withdrawal symptoms. Use will be monitored via self-report for telephone follow-ups. At clinic visits, patients will be asked to bring their e-cigarettes, used and unused cartridges/pods, and purchasing receipts. Patients will be advised regarding the signs and symptoms of nicotine toxicity and of an allergic reaction.

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

Varenicline Plus Counseling

OTHER

All patients will begin varenicline in-hospital upon randomization. For the first 3 days, patients will take a 0.5 mg tablet once a day. They will then take a 0.5 mg tablet twice a day for the following 4 days, and one 1 mg tablet twice a day from day 8 onward for the remainder of the 12-week treatment. Use will be monitored via self-report for telephone follow-ups and return of all unused tablets at the end of the treatment period. Should a patient experience severe side effects (such as headache, nausea, vomiting, dizziness, dyspepsia, fatigue, insomnia, abnormal dreams, constipation, or flatulence) on day 8 onward, the varenicline dose should be reduced from 1 mg twice daily to 0.5 mg twice daily prior to study medication discontinuation.

Other: Varenicline Plus Counseling

Interventions

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

Varenicline and nicotine e-cigarettes plus counseling

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

Varenicline Plus Counseling OTHER

Varenicline plus counseling

Varenicline Plus Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows:
• i. MI, defined by positive troponin T, troponin I, or CK-MB levels (as defined by institution-specific cut-offs) and ≥ 1 of the following:
• Ischemic symptoms for ≥ 20 min;
• Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
• Development of pathological Q waves on the ECG
• ii. Unstable angina with significant coronary artery disease, defined by all of the following:
• Ischemic symptoms for ≥ 20 min;
• ECG changes indicative of ischemia (ST-segment changes);
• At least one lesion ≥ 50% on angiogram performed during the current hospitalization.
• \[Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.\]
• Outpatients with the following diagnoses/conditions:
• i. Cardiovascular:
• Coronary artery disease documented with angiography or coronary CT;
• Previous ACS, MI, stable or UA;
• Previous coronary revascularization (e.g. PCI or CABG). ii. Renovascular:

You may not qualify if:

• Pregnant or lactating females;
• Use of any of the following in the 30 days prior to eligibility assessment:
• i. Varenicline or bupropion for smoking cessation; ii. Nicotine or non-nicotine e-cigarettes; iii. Other anti-craving medication (e.g., naltrexone, acamprosate) with the potential to alter substance-seeking behaviors;
• 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);
• NYHA or Killip Class III or IV at the time of randomization;
• Any unstable psychiatric disorder (as per enrolling physician);
• Renal impairment with creatinine levels ≥2 times upper limit of normal or eGFR ≤15;
• Use of any illegal drugs in the past year;
• Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period. \[Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.\]

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (13)

Fraser Clinical Trials

New Westminster, British Columbia, V3L 3W4, Canada

RECRUITING

Dr. Georges-L.-Dumont University Hospital Center

Moncton, New Brunswick, E1C 2Z3, Canada

RECRUITING

NL Health Sciences

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

St. Joseph's Hospital

London, Ontario, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Centre Hospitalier de L'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Cardiovascular Diseases; Smoking Cessation; Vaping

Interventions

Varenicline; Counseling

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Tabitha Finch

CONTACT

514-340-8222; ASAP.Trial@ladydavis.ca

Carole Bohbot

CONTACT

514-340-8222; carole.bohbot@ladydavis.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 25, 2022
• Study Start: February 2, 2023
• Primary Completion: March 7, 2026
• Study Completion (Estimated): March 7, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)