Aggressive smoking cessation for patients with heart conditions

Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial

This study is testing if a stronger smoking cessation program using both medication and counseling can help people with heart conditions quit smoking more effectively than just medication and counseling alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 798 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital (other)
• Locations: 13 sites (New Westminster, British Columbia and 12 other locations)
• Trial ID: NCT05257629 on ClinicalTrials.gov

What this trial studies

The ASAP Trial is a 5-year, multi-centre, randomized controlled trial designed to evaluate the effectiveness of aggressive smoking cessation therapy in individuals at high cardiovascular risk. It will enroll 798 adult patients who smoke at least 10 cigarettes daily and are either hospitalized for acute coronary syndrome or are outpatients with elevated cardiovascular risk. Participants will be randomly assigned to receive either a combination of varenicline and nicotine e-cigarettes along with counseling or varenicline plus counseling alone for 12 weeks, followed by a 52-week follow-up to assess outcomes. This trial aims to improve smoking cessation rates among a vulnerable population that is at risk for further cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates are adults who smoke at least 10 cigarettes per day and have been diagnosed with acute coronary syndrome or are at elevated cardiovascular risk.

Not a fit: Patients who do not smoke or are not motivated to quit smoking may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly improve smoking cessation rates and reduce cardiovascular risks for patients with acute coronary syndrome.

How similar studies have performed: Previous studies have shown that varenicline is effective for smoking cessation, but this combination approach with nicotine e-cigarettes is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. 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:
   1. Ischemic symptoms for ≥ 20 min;
   2. Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
   3. Development of pathological Q waves on the ECG

   ii. Unstable angina with significant coronary artery disease, defined by all of the following:
   1. Ischemic symptoms for ≥ 20 min;
   2. ECG changes indicative of ischemia (ST-segment changes);
   3. At least one lesion ≥ 50% on angiogram performed during the current hospitalization.

   \[Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.\]

   OR

   Outpatients with the following diagnoses/conditions:

   i. Cardiovascular:
   1. Coronary artery disease documented with angiography or coronary CT;
   2. Previous ACS, MI, stable or UA;
   3. Previous coronary revascularization (e.g. PCI or CABG). ii. Renovascular:

   a. Chronic kidney disease. iii. Cerebrovascular:

   a. Previous cerebral infarction or transient cerebral ischemic attack. iv. Peripheral vascular:
   1. Abdominal aortic aneurysm \> 3.0 cm or previous aortic aneurysm surgery;
   2. Ankle-brachial pressure index of \< 0.9 or intermittent claudication;
   3. Documented carotid artery disease;
   4. Lower-limb amputation;
   5. Previous lower-limb bypass surgery or angioplasty.

   v. ≥1 risk factors:
   1. BMI ≥ 27 kg/m2;
   2. Dyslipidemia;
   3. Family history (first degree relative: parents or siblings only) of coronary heart disease or stroke before the age of 60 years;
   4. Hypertension;
   5. Males aged ≥ 55 years/females aged ≥ 60 years;
   6. Diabetes mellitus. vi. Heart-related conditions:

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   1. Atrial fibrillation or flutter;
   2. Cardiomyopathy;
   3. Heart failure;
   4. Left ventricular hypertrophy (evidenced by echocardiography or ECG);
   5. Valvular disease (evidenced by echocardiography).
2. Smoked on average ≥ conventional cigarettes/day for the past year;
3. Age ≥18 years;
4. Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5);
5. Able to understand and provide informed consent in English or French;
6. If randomized to the combination arm (varenicline and e-cigarette plus counseling), willing and able to purchase e-cigarettes with the following properties: rechargeable, closed system that uses sealed cartridges or pods, tobacco or no flavor only, and nicotine strength of 20 mg/ml (2%) or less;
7. Likely to be available for 52 weeks of follow-up.

Exclusion Criteria:

1. Pregnant or lactating females;
2. 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;
3. Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment \[Note: If participant is prescribed non-study NRT while hospitalized, they can continue using the non-study NRT until being discharged, even while taking the investigational products. Upon discharge, use of the non-study NRT should be stopped.\];
4. Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 days consecutively in the past year;
5. Previous serious adverse reaction to varenicline and/or e-cigarettes (nicotine or non-nicotine);
6. NYHA or Killip Class III or IV at the time of randomization;
7. Any unstable psychiatric disorder (as per enrolling physician);
8. Renal impairment with creatinine levels ≥2 times upper limit of normal or eGFR ≤15;
9. Use of any illegal drugs in the past year;
10. Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period. \[Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.\]

Where this trial is running

New Westminster, British Columbia and 12 other locations

• Fraser Clinical Trials — New Westminster, British Columbia, Canada (RECRUITING)
• Dr. Georges-L.-Dumont University Hospital Center — Moncton, New Brunswick, Canada (RECRUITING)
• NL Health Sciences — St. John's, Newfoundland and Labrador, Canada (RECRUITING)
• Queen Elizabeth II Health Sciences Center — Halifax, Nova Scotia, Canada (RECRUITING)
• St. Joseph's Hospital — London, Ontario, Canada (RECRUITING)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
• Montreal Heart Institute — Montreal, Quebec, Canada (RECRUITING)
• Centre Hospitalier de L'Universite de Montreal — Montreal, Quebec, Canada (RECRUITING)
• Montreal General Hospital — Montreal, Quebec, Canada (RECRUITING)
• Jewish General Hospital — Montreal, Quebec, Canada (RECRUITING)
• Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Quebec, Canada (RECRUITING)
• Royal University Hospital — Saskatoon, Saskatchewan, Canada (RECRUITING)

Study contacts

• Study coordinator: Tabitha Finch

Conditions: Acute Coronary Syndrome, Cardiovascular Diseases, acute coronary syndrome, smoking cessation, randomized controlled trial, varenicline, e-cigarettes, cardiovascular disease