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

NCT03837704 | Completed Results

• 1 other identifier: P1-AAA-02-JP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 13

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.

Conditions

Smoking; Abdominal Aortic Aneurysm; IQOS Use

Outcome Measures

Primary Outcomes (1)

• AAA Annual Growth Rate Over Time

  AAA annual growth rate will be measured in AAA patients who switch from smoking cigarettes to using IQOS, and AAA patients who continue to smoke CC, as compared to AAA patients who had stopped smoking. Maximum minor-axis AAA diameter in mm will be measured. Annual growth rate will be calculated by annualizing the slope of the linear regression over the available diameter measurements.

  At 6-month intervals from baseline to V8 (month 36)

Secondary Outcomes (13)

• Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time

  From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years

• Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time

  From time of AAA diagnosis (prior to study participation) until V8 (month 36), a time frame of up to 7 years

• Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture

  From baseline to V8 (month 36)

• Incidence of AAA Growth Above 5 mm Within 6 Months

  At 6-month intervals from baseline to V8 (month 36)

• AAA Patients With an Overall Maximum Minor-axis AAA Diameter of >55mm in Male Patients and >50mm in Female Patients

  From baseline to V8 (month 36)

Study Arms (3)

IQOS Arm

ACTIVE COMPARATOR

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

Other: IQOS

CC Arm

ACTIVE COMPARATOR

Patients diagnosed with AAA, continuing to smoke cigarettes

Other: Cigarette

Smoking Cessation Arm

ACTIVE COMPARATOR

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

Other: Smoking Cessation

Interventions

IQOS OTHER

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

IQOS Arm

Cigarette OTHER

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

CC Arm

Smoking Cessation 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)

Smoking Cessation Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (13)

Chiba-Nishi General Hospital

Matsudo, Chiba, 270-2251, Japan

Location

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, 279-0001, Japan

Location

Fujita General Hospital

Fujita, Fukushima, 969-1793, Japan

Location

Kitakanto Cardiology Hospital

Shizukawa, Gunma, 377-0061, Japan

Location

Shonan Kamakura General Hospital

Okamoto, Kamakura, 247-8533, Japan

Location

Atsugi City Hospital

Atsugi, Kanagawa, 243-8588, Japan

Location

AOI Universal Hospital

Kawasaki, Kanagawa, 210-0822, Japan

Location

Shin-Yurigaoka General Hospital

Kawasaki, Kanagawa, 215-0026, Japan

Location

Saitama Cardiovascular and Respiratory Center

Itai, Kumagaya, 360-0197, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-8522, Japan

Location

Kasukabe Chuo General Hospital

Kasukabe, Saitama, 344-0063, Japan

Location

Okitama Public General Hospital

Nanyō, Yamagata, 992-0472, Japan

Location

Omichikai Morinomiya Hospital

Osaka, 536-0025, Japan

Location

MeSH Terms

Conditions

Smoking; Aortic Aneurysm, Abdominal

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Behavior; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

This was an exploratory study not powered to detect a difference in AAA diameter between the different study arms. Due to patient recruitment challenges, only 48 patients out of the 114 planned were enrolled and the study was shortened from 5 to 3 years. Due to the limited sample size potential confounders could also not be adjusted for.

Results Point of Contact

• Title: Global Head Clinical Development & Operations
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Xavier Jaumont, MD

  Philip Morris Products SA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 12, 2019
• Study Start: October 3, 2018
• Primary Completion: April 6, 2023
• Study Completion: August 28, 2023
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Locations

JP (13)