Phase
Condition
Angina
Vascular Diseases
Coronary Artery Disease
Treatment
Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)
Varenicline Plus Counseling
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients currently hospitalized or being discharged from hospital who have sufferedan ACS, defined as follows: i. MI, defined by positive troponin T, troponin I, or CK-MB levels (as defined byinstitution-specific cut-offs) and ≥ 1 of the following:
Ischemic symptoms for ≥ 20 min;
Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation ordepression);
Development of pathological Q waves on the ECG ii. Unstable angina with significant coronary artery disease, defined by all of thefollowing:
Ischemic symptoms for ≥ 20 min;
ECG changes indicative of ischemia (ST-segment changes);
At least one lesion ≥ 50% on angiogram performed during the currenthospitalization.
[Note: patients who undergo cardiac catheterization or percutaneous coronaryintervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligibleprovided they are able to start varenicline in-hospital and nicotine e-cigarette atdischarge.] OR 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: 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 coronaryheart 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 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 noflavor only, and nicotine strength of 20 mg/ml (2%) or less;
Likely to be available for 52 weeks of follow-up.
Exclusion
Exclusion Criteria:
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-nicotinee-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 eligibilityassessment [Note: If participant is prescribed non-study NRT while hospitalized,they can continue using the non-study NRT until being discharged, even while takingthe investigational products. Upon discharge, use of the non-study NRT should bestopped.];
Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 daysconsecutively in the past year;
Previous serious adverse reaction to varenicline and/or e-cigarettes (nicotine ornon-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) duringthe study period. [Note: use of cannabis which is not smoked is permitted (e.g.,edibles, ingested or vaped oils). However, methods which involve combustion couldinvalidate biochemical validation via exhaled carbon monoxide.]
Study Design
Study Description
Connect with a study center
Dr. Georges-L.-Dumont University Hospital Center
Moncton, New Brunswick E1C 2Z3
CanadaActive - Recruiting
NL Health Sciences
Saint John's, Newfoundland and Labrador A1B 3V6
CanadaActive - Recruiting
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia B3H 3A7
CanadaActive - Recruiting
St. Joseph's Hospital
London, Ontario
CanadaActive - Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaActive - Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
Montreal General Hospital
Montreal, Quebec H3G 1A4
CanadaActive - Recruiting
Centre Hospitalier de L'Universite de Montreal
Montréal, Quebec H2X 3E4
CanadaActive - Recruiting
Jewish General Hospital
Montréal, Quebec
CanadaSite Not Available
Montreal Heart Institute
Montréal, Quebec H1T 1C8
CanadaActive - Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec City, Quebec G1V 4G5
CanadaActive - Recruiting
Royal University Hospital
Saskatoon, Saskatchewan S7N 0W8
CanadaActive - Recruiting
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