Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression (SWITCH)
Coronary Artery Disease, Coronary Atherosclerosis, Nicotine Dependence
About this trial
This is an interventional supportive care trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Adults aged >18 years and <75 years Subjects with stable chronic coronary syndrome defined as the presence of at least one coronary artery stenosis >=20% due to coronary plaque visible on coronary computed tomography angiography (CCTA), in an artery with a reference diameter > 2.0mm History of smoking pack-years ≥10 (Pack-years will be calculated by taking the average number of cigarettes smoked per day divided by 20 and multiplied by the number of years smoked), based on self-reporting Current smokers with a minimum of self-reported current smoking pattern of >10 cigarettes/day during the last 6 months prior to screening, smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL) Patients that have been advised to quit smoking and informed of a smoking risk and cessation programs (per local SOC) and who are still not willing to set a quit date within the next 30 days at screening Stable treatment for coronary atherosclerosis according to the guidelines Have understood the study and have signed informed consent Exclusion Criteria: Any acute cardiovascular event (i.e. ACS, MI, Stroke, TIA, Limb ischemia), unstable angina or revascularization within 30 days prior to screening Planned coronary intervention (PCI, CABG) at screening Previous CABG Preexisting heart failure with reduced ejection fraction (EF <50%) Severe uncontrolled hypertension (at the discretion of investigator) Diabetes Subjects with documented genetic familial hypercholesterolemia Subjects have known serious infection or chronic inflammatory systemic disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis) Subjects have a known non-cardiovascular disease that is associated with poor prognosis (e.g. metastatic cancer) Patient with currently active cancer or history of cancer within the last 5 years Subjects have hypersensitivity or any other warnings listed in the local labeling for THS Subjects have hypersensitivity to imaging iodine contrast agents GFR<45 ml/min/1,73 m2 Subjects who could not participate for any reason other than medical (e.g., psychological and/or social reason) per Investigator's judgment Subjects have any other clinical condition that would jeopardize the subject's safety while participating in this study, per Investigator's judgment Female subject is pregnant or breast-feeding, or planning to become pregnant during the study Subjects have previously participated in this study, or in an interventional study (drug or medical device) within 30 days of screening (participation in observational studies/registries allowed) Subjects have a close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g. employee or student of the investigational site) Subjects are current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)
Sites / Locations
- National Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
combustion tobacco
heated tobacco