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      Status: Withdrawn (The study was stopped before enrollment, after a feasibility review revealed we would be unable to measure the primary endpoint (flow mediated dilation -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