Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects Wi… (NCT05566678) | Clinical Trial Compass
WithdrawnNot Applicable
Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease
Stopped: The study was stopped before enrollment, after a feasibility review revealed we would be unable to measure the primary endpoint (flow mediated dilation - FMD) with a high degree of reproducibility and minimum variability in a multi-country setting.
0Started 2023-03-15
Plain-language summary
The purpose of this study is to demonstrate improvement in flow mediated dilation (FMD), a functional endpoint associated with the progression of atherosclerosis, when switching from cigarettes to the Tobacco Heating System (THS) in subjects with peripheral arterial disease (PAD) and/or coronary artery disease (CAD). The study is planned to be conducted in the US, Europe, and Asia.
Who can participate
Age range40 Years – 70 Years
SexALL
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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 …