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

NCT ID: NCT03837704

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-03
• Study Completion Date: 2023-08-28

Brief Summary

The purpose of this study was to evaluate the reduction of the Abdominal Aortic Aneurysm (AAA) annual growth rate in patients who switched from smoking cigarettes to using IQOS as compared to patients who continued to smoke cigarettes, and to patients who had quit smoking. The study also aimed 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 further evaluated 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 Biomarkers of Potential Harm (BoPH) linked to smoking related diseases.

Detailed Description

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

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

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

Conditions

Smoking; Abdominal Aortic Aneurysm; IQOS Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IQOS Arm

Patients diagnosed with AAA, switching from cigarette smoking to IQOS use

Group Type: ACTIVE_COMPARATOR

IQOS

Intervention Type: OTHER

AAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions.

CC Arm

Patients diagnosed with AAA, continuing to smoke cigarettes

Group Type: ACTIVE_COMPARATOR

Cigarette

Intervention Type: OTHER

AAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.

Smoking Cessation Arm

Patients diagnosed with AAA, who have completely stopped smoking and are not using any other tobacco or nicotine-containing product(s)

Group Type: ACTIVE_COMPARATOR

Smoking Cessation

Intervention Type: OTHER

AAA patients who have completely quit smoking will continue to remain abstinent from smoking cigarettes or using any tobacco or nicotine-containing product(s)

Interventions

IQOS

AAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions.

Intervention Type: OTHER

Cigarette

AAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.

Intervention Type: OTHER

Smoking Cessation

AAA patients who have completely quit smoking will continue to remain abstinent from smoking cigarettes or using any tobacco or nicotine-containing product(s)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient diagnosed with AAA (infrarenal, fusiform type) with a current aortic maximum minor-axis diameter of 30 to ≤ 49 mm (in male patient) and 30 to ≤ 44 mm (in female patient).
• Patient has smoked on a daily basis (no brand restrictions) for at least 5 years prior to AAA diagnosis, based on self-reporting
• Patient is ready to comply with the study protocol (e.g., to use their assigned product/regimen during the course of the study)

• Patient has smoked on average at least 5 commercially available CC per day (no brand restriction) for the last 12 months, based on self-reporting. Intermittent attempts to quit smoking not exceeding 2 months or short-term interruption of smoking up to 10 days within the last 12 months will be allowed. Smoking status will be verified based on a urinary cotinine test (i.e., cotinine ≥ 200 ng/mL).
• Not intending to quit smoking within the next 6 months after having been advised to quit smoking.

• Patient had completely quit smoking and stopped the use of any other tobacco or nicotine-containing products within 6 months after AAA diagnosis, and is still abstinent at Screening and at Baseline. Smoking status will be verified based on a urinary cotinine test (i.e., cotinine < 100 ng/mL).

Exclusion Criteria

• Patient is legally incompetent, physically or mentally incapable of giving consent.
• Patient is a current or former employee of the tobacco industry or their first-degree relatives (parent and child); patient is an employee of the investigational site or any other parties involved in the study or their first-degree relatives (parent and child).
• Patient has been previously screened or enrolled in this study or was enrolled in any clinical study within 3 months prior to the Screening Visit.
• Female patient who is pregnant or breast-feeding.
• Patient is ineligible as judged by the Investigator to participate in the study for any reason.
• Patient with acute severe cardiovascular events or respiratory diseases, within the last 3 months; with currently active cancer or history of cancer within the last 5 years; with dissecting aneurysm(s) of the aorta; with infrarenal pseudo-AAA (false AAA); with a diagnosis of COPD Stage 3 and 4 in the medical history; with a recent (within 1 year) or current history of alcohol or other substance abuse based on self-reporting.
• Patient with a diagnosis of concomitant genetic diseases such as but not limited to Marfan syndrome, Loeys-Dietz syndrome, Vascular Ehlers-Danlos syndrome, Turner syndrome, Polycystic kidney disease, Noonan syndrome, Alagile syndrome, Arterial tortuosity syndrome and Cutis laxa.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philip Morris Products S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Jaumont, MD

Role: STUDY_CHAIR

Philip Morris Products SA

Locations

Chiba-Nishi General Hospital

Matsudo, Chiba, Japan

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Fujita General Hospital

Fujita, Fukushima, Japan

Kitakanto Cardiology Hospital

Shizukawa, Gunma, Japan

Shonan Kamakura General Hospital

Okamoto, Kamakura, Japan

Atsugi City Hospital

Atsugi, Kanagawa, Japan

AOI Universal Hospital

Kawasaki, Kanagawa, Japan

Shin-Yurigaoka General Hospital

Kawasaki, Kanagawa, Japan

Saitama Cardiovascular and Respiratory Center

Itai, Kumagaya, Japan

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Okitama Public General Hospital

Nanyō, Yamagata, Japan

Omichikai Morinomiya Hospital

Osaka, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P1-AAA-02-JP

Identifier Type: -

Identifier Source: org_study_id