Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease

This is an interventional other trial for Cardiovascular Diseases focused on measuring Flow Mediated Dilation, Atherosclerosis Read More

Main Inclusion Criteria:

• History of coronary artery disease, defined as documented CAD (stable) with coronary artery stenosis on coronary angiogram ≥50% (incl. Percutaneous Coronary Intervention (PCI) / Coronary artery bypass graft surgery (CABG)) in the medical history or previously documented acute coronary syndrome (ACS) / myocardial infarction occurring more than 1 month prior to V1. AND / OR, History of peripheral artery disease (PAD) defined as ABI <0.9 or TBI <0.6 or clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Fontaine's stages I, IIa and IIb.
• Body mass index (BMI) 17.6-40.0 kg/m2 and body weight > 50 kg (male) or 40 kg (female).
• Subject has a smoking history of at least 10 years.
• Subject has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year prior to V1.
• Subject has been smoking ≥ 10 commercially available cigarettes/day on average (no brand restriction) for at least 1 year prior to V1 (based on self-reporting).
• For subjects not willing to quit smoking only: have been advised to quit smoking and informed of smoking risks and of cessation programs and is still not willing to quit during the study duration.
• Subjects willing to quit smoking only: willing to and set a target quit date (TQD) within the next 28 days at V1 as assessed by self-reported questions

Main Exclusion Criteria:

• Planned peripheral or coronary intervention or surgical procedure.
• Unstable angina pectoris.
• Critical limb ischemia (absolute peripheral pressures <50mmHg).
• Recent (< 30 days) PAD revascularization therapy prior to V1.
• Recent ACS / myocardial infarction or stroke / TIA <30 days prior to V1.
• Pre-existing symptomatic heart failure with reduced ejection fraction (EF<35%).
• Planned peripheral or coronary intervention or surgical procedure related to CAD or PAD.
• Subjects with spirometry values indicating chronic obstructive pulmonary disease (COPD) GOLD* Stage 3 or 4 (FEV1/FVC <0.7 & FEV1 <50% predicted [post-BD])
• Existing known serious infection or chronic inflammatory systemic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, uncontrolled diabetes (HbA1c ≥ 7.0 % [or ≥ 53.0 mmol/mol]) or uncontrolled hypertension (systolic blood pressure≥140 mmHg and / or diastolic blood pressure ≥90 mmHg., stage 4 and 5 chronic kidney disease, etc…).
• Currently active cancer or history of cancer within the last 5 years prior to V1.
• History of alcohol and / or drug abuse (other than tetrahydrocannabinol [THC]).
• Positive serology test (human immunodeficiency virus (HIV) 1/2), hepatitis B and / or C).
• Female subject is pregnant or breastfeeding, (a urine pregnancy test will be performed at V1 and V2)
• Previous participation in this study, or participation in an investigational study (drug or medical device) within 4 weeks before V1 (participation in observational studies/registries allowed)
• For women of childbearing potential, female subject who does not agree to using an acceptable method of effective contraception during the entire study.

[*Global Initiative for Obstructive Lung Disease]