SmokingNCT03837704
Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking.
A study testing IQOS, Cigarette and Smoking Cessation in people with Smoking and Abdominal Aortic Aneurysm, run by Philip Morris Products S.A. at 13 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Smoking, Abdominal Aortic Aneurysm, IQOS Use
- What is being tested?
- IQOS, Cigarette and Smoking Cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 13 sitesJapan
- Study dates
- 3 Oct 2018to 28 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Atsugi City Hospital
Atsugi, Kanagawa, 243-8588
Fujita General Hospital
Fujita, Fukushima, 969-1793
Saitama Cardiovascular and Respiratory Center
Itai, Kumagaya, 360-0197
Kasukabe Chuo General Hospital
Kasukabe, Saitama, 344-0063
AOI Universal Hospital
Kawasaki, Kanagawa, 210-0822
Shin-Yurigaoka General Hospital
Kawasaki, Kanagawa, 215-0026
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-8522
Chiba-Nishi General Hospital
Matsudo, Chiba, 270-2251
Okitama Public General Hospital
Nanyō, Yamagata, 992-0472
Shonan Kamakura General Hospital
Okamoto, Kamakura, 247-8533
Omichikai Morinomiya Hospital
Osaka, 536-0025
Kitakanto Cardiology Hospital
Shizukawa, Gunma, 377-0061
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, 279-0001
About this study
Official title: A Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Evaluate the Abdominal Aortic Aneurysm (AAA) Growth Rate in Adult Smoking Patients Randomized to Either Cigarette Smoking or IQOS Use and to Compare With the AAA Growth Rate in Patients Who Had Stopped Smoking
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.
Read the 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
- Being tested
- IQOS, Cigarette, Smoking Cessation
- Medical subject headings
- Smoking, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQOSOther
AAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions.
CigaretteOther
AAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
Smoking CessationOther
AAA patients who have completely quit smoking will continue to remain abstinent from smoking cigarettes or using any tobacco or nicotine-containing product(s)
| Study group | Role | What they receive |
|---|---|---|
| IQOS Arm | Active comparator | Patients diagnosed with AAA, switching from cigarette smoking to IQOS use Receives: Other: IQOS |
| CC Arm | Active comparator | Patients diagnosed with AAA, continuing to smoke cigarettes Receives: 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) Receives: Other: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This outcome measured the percentage of subjects without surgery or endovascular repair over time in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking.
Measured: 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
This outcome measured the percentage of subjects without surgery or AAA rupture over time in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking.
Measured: 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
The incidence of open surgical AAA treatment or AAA endovascular repair and AAA rupture will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue to smoke CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually.
Measured: From baseline to V8 (month 36)
Incidence of AAA Growth Above 5 mm Within 6 Months
Incidence of AAA growth above 5 mm within 6 months will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually by counting the number of patients with an increase in maximum minor-axis AAA diameter of more than 5 mm within 6 months.
Measured: 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
The number of AAA patients with an overall maximum minor-axis AAA diameter >55mm in male AAA patients and >50mm in female AAA patients will be counted in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. (Note that the 95% CI is calculated by exact method (Clopper-Pearson) and refers to CI for a proportion).
Measured: From baseline to V8 (month 36)
Systolic Blood Pressure
This cardiovascular BoPH (systolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Measured: From V1 (screening) to V8 (month 36)
Urinary Nicotine Equivalents (NEQ)
To measure nicotine exposure over time in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC, and AAA patients who had stopped smoking. (NEQ adjusted for creatinine (mg/g creat)).
Measured: From baseline to V8 (month 36)
Diastolic Blood Pressure
This cardiovascular BoPH (diastolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Measured: From V1 (screening) to V8 (month 36)
Body Weight
This cardiovascular BoPH (body weight) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Measured: From V1 (screening) to V8 (month 36)
Waist Circumference
This cardiovascular BoPH (waist circumference) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Measured: From V1 (screening) to V8 (month 36)
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Measured: From baseline to V8 (month 36)
Total N-nitrosonornicotine (Total NNN)
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Measured: From baseline to V8 (month 36)
2-cyanoethylmercapturic Acid (2-CyEMA)
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking.
Measured: From baseline to V8 (month 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start3 Oct 2018
- Primary completion6 Apr 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xavier Jaumont, MD, Study chair, Philip Morris Products SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837704
- Sponsor's protocol ID
- P1-AAA-02-JP
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2019
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Evaluate the Abdominal Aortic Aneurysm (AAA) Growth Rate in Adult Smoking Patients Randomized to Either Cigarette Smoking or IQOS Use and to Compare With the AAA Growth Rate in Patients Who Had Stopped Smoking
- ClinicalTrials.gov ID
- NCT03837704
- Acronym / sponsor ID
- P1-AAA-02-JP
- Conditions
- Smoking, Abdominal Aortic Aneurysm, IQOS Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IQOS Arm | Active comparator | Other: IQOSPatients diagnosed with AAA, switching from cigarette smoking to IQOS use |
| CC Arm | Active comparator | Other: CigarettePatients diagnosed with AAA, continuing to smoke cigarettes |
| Smoking Cessation Arm | Active comparator | Other: Smoking CessationPatients diagnosed with AAA, who have completely stopped smoking and are not using any other tobacco or nicotine-containing product(s) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQOSAAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions. | Other | IQOS Arm |
| CigaretteAAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions. | Other | CC Arm |
| Smoking CessationAAA patients who have completely quit smoking will continue to remain abstinent from smoking cigarettes or using any tobacco or nicotine-containing product(s) | Other | Smoking Cessation Arm |
Primary outcome
AAA Annual Growth Rate Over Time
Time frame: At 6-month intervals from baseline to V8 (month 36)
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.
13 secondary outcomes
Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time
Time frame: 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
Time frame: 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
Time frame: From baseline to V8 (month 36)
Incidence of AAA Growth Above 5 mm Within 6 Months
Time frame: 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
Time frame: From baseline to V8 (month 36)
Systolic Blood Pressure
Time frame: From V1 (screening) to V8 (month 36)
Urinary Nicotine Equivalents (NEQ)
Time frame: From baseline to V8 (month 36)
Diastolic Blood Pressure
Time frame: From V1 (screening) to V8 (month 36)
Body Weight
Time frame: From V1 (screening) to V8 (month 36)
Waist Circumference
Time frame: From V1 (screening) to V8 (month 36)
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Time frame: From baseline to V8 (month 36)
Total N-nitrosonornicotine (Total NNN)
Time frame: From baseline to V8 (month 36)
2-cyanoethylmercapturic Acid (2-CyEMA)
Time frame: From baseline to V8 (month 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Jaumont, MD study chair
Philip Morris Products SA
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQOS, Cigarette and Smoking Cessation in people with Smoking and Abdominal Aortic Aneurysm, run by Philip Morris Products S.A. at 13 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AAA Annual Growth Rate Over Time (time frame: At 6-month intervals from baseline to V8 (month 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.