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New treatment option for Acute Coronary Syndrome
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)?
Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) is an investigational medicine, given as an once-daily, being studied as a potential treatment for acute coronary syndrome.
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 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.
- 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
- Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows: i. MI, defined by positive troponin...
- 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;
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. Nicotine or...
- 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
- 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...
- 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)...
- 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: a. Chronic kidney disease. iii. Cerebrovascular: a. Previous cerebral infarction or transient cerebral ischemic attack. iv. Peripheral vascular:
- 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;
- Previous lower-limb bypass surgery or angioplasty. v. ≥1 risk factors:
- 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;
- Diabetes mellitus. vi. Heart-related conditions:
- 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. Other anti-craving medication (e.g...
- 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). However, methods...
The study team makes the final eligibility decision.
Where it's taking place
- 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
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.