Acute Coronary Syndrome study: Combination Therapy Arm vs Varenicline Plus Counseling
Official title Aggressive Smoking Cessation Trial (ASAP)
ClinicalTrials.gov ID: NCT05257629
What this study is testing
What is Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)?
an investigational combination of varenicline, nicotine e‑cigarettes and counseling being studied for smoking cessation in patients after acute coronary syndrome is designed to reduce nicotine cravings by partially activating nicotine receptors (varenicline) and delivering nicotine through e‑cigarettes
Also referred to as varenicline (Champix), nicotine e‑cigarettes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a strong quitting plan that includes medication, e‑cigarettes and counseling works safely and is tolerated better than medication and counseling alone.
- Who it's for
- Adults who smoke at least 10 cigarettes a day, want to quit, and have had a recent heart event or have high heart disease risk.
- What's involved
- Participants will be randomly assigned to either varenicline plus nicotine e‑cigarettes and counseling, or varenicline plus counseling for 12 weeks, with follow‑up visits for a year.
- Time commitment
- The trial lasts about 12 weeks of treatment plus a 52‑week follow‑up, with regular clinic visits during that time.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ischemic symptoms for ≥ 20 min;
- Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
- Ischemic symptoms for ≥ 20 min;
- ECG changes indicative of ischemia (ST-segment changes);
- Coronary artery disease documented with angiography or coronary CT;
You likely can't join 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.
- Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment [Note: If participant is prescribed non-study NRT while...
- 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;
See the full eligibility criteria
- Ischemic symptoms for ≥ 20 min;
- Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
- Ischemic symptoms for ≥ 20 min;
- ECG changes indicative of ischemia (ST-segment changes);
- Coronary artery disease documented with angiography or coronary CT;
- Previous ACS, MI, stable or UA;
- Abdominal aortic aneurysm \> 3.0 cm or previous aortic aneurysm surgery;
- Ankle-brachial pressure index of \< 0.9 or intermittent claudication;
- Documented carotid artery disease;
- Lower-limb amputation;
- BMI ≥ 27 kg/m2;
- Dyslipidemia;
- Family history (first degree relative: parents or siblings only) of coronary heart disease or stroke before the age of 60 years;
- Hypertension;
- Males aged ≥ 55 years/females aged ≥ 60 years;
- Atrial fibrillation or flutter;
- Cardiomyopathy;
- Heart failure;
- Left ventricular hypertrophy (evidenced by echocardiography or ECG);
- Valvular disease (evidenced by echocardiography).
- Smoked on average ≥ conventional cigarettes/day for the past year;
- Age ≥18 years;
- Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5);
- Able to understand and provide informed consent in English or French;
- If assigned by chance 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...
- Likely to be available for 52 weeks of follow-up.
- 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- New Westminster, British Columbia, Canada
- Moncton, New Brunswick, Canada
- St. John's, Newfoundland and Labrador, Canada
- Halifax, Nova Scotia, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Westminster, British Columbia, Canada; Moncton, New Brunswick, Canada; St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.