Last updated on April 2020

Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS Continue Smoking or Quit Smoking.

Brief description of study

The purpose of this study is to evaluate the reduction of the Abdominal Aortic Aneurysm (AAA) annual growth rate in patients who switch from smoking cigarettes to using IQOS as compared to patients who continue to smoke cigarettes. The study also aims to provide context to the scale of reduction in the growth rate, by comparing the AAA annual growth rates for continuing to smoke and switching to IQOS with the AAA annual growth rate in smokers who had stopped smoking. The study will further evaluate the effects of switching to IQOS on co-morbidities observed in AAA patients that are related to smoking as well as to assess the effects on relevant clinical risk endpoints linked to smoking related diseases.

Detailed Study Description

This is a controlled, open-label, 3-arm parallel group, multi-center study in patients diagnosed with Abdominal Aortic Aneurysm (AAA) to evaluate the AAA annual growth rate in adult smokers randomized to either continue smoking combustible cigarettes (CC) or to switch to IQOS and in adults who had stopped smoking, as a non-randomized control arm.

This is a descriptive study, designed to gain an understanding of how changes in smoking behaviors impact AAA growth rate and disease progression. Therefore, there are no formal statistical hypotheses to be tested.

Smoking patients with AAA who did not quit smoking after their AAA diagnosis, and who are not intending to quit within the next 6 months will be screened for enrollment and randomization in the CC and IQOS arms if all other eligibility criteria are met.

Smoking patients with AAA who had completely stopped smoking and using of any other tobacco or nicotine-containing products within 2 months of their AAA diagnosis, and are still abstinent at the time of the Screening Visit and of the Baseline Visit will be screened to be enrolled in the smoking cessation (SC) arm without randomization.

Clinical Study Identifier: NCT03837704

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