Clinical Studies

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

    First posted
    Oct 4, 2022
    Identifier
    NCT05566678
    Publication Site URL
    Topic
    Official Title

    A 12-month, 3-group, Preference, Multi-center Study to Demonstrate the Effects of Switching From Cigarettes to Tobacco Heating System (THS) on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease

    Brief 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.

    Summary

    Status: Withdrawn (The study was stopped before enrollment, after a feasibility review revealed we would be unable to measure the primary endpoint (flow mediated dilation - FMD)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.)

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