N/A
Completed N=48
Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking.
Smoking · Abdominal aortic aneurysm · IQOS Use
Source: ClinicalTrials.gov NCT03837704 ↗
Enrolled (actual)
48
Serious AEs
31.3%
Results posted
Aug 2025
Primary outcomePrimary: AAA Annual Growth Rate Over Time — 1.80; 1.87; 1.27 (mm/year)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AAA Annual Growth Rate Over Time |
1.80; 1.87; 1.27 | — |
| SECONDARY Percentage of Subjects Without Open Surgical AAA Treatment or AAA Endovascular Repair Over Time |
100.0; 100.0; 100.0; 100.0; 100.0; 87.5 | — |
| SECONDARY Percentage of Subjects Without Open Surgical AAA Treatment or AAA Rupture Over Time |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Incidence of Open Surgical AAA Treatment or AAA Endovascular Repair and AAA Rupture |
0.05; 0.05; 0.05; 0.00; 0.00; 0.00 | — |
| SECONDARY Incidence of AAA Growth Above 5 mm Within 6 Months |
0; 0; 0 | — |
| SECONDARY AAA Patients With an Overall Maximum Minor-axis AAA Diameter of >55mm in Male Patients and >50mm in Female Patients |
0; 0; 0 | — |
| SECONDARY Systolic Blood Pressure |
134.8; 128.0; 124.0; 132.5; 128.9; 135.9 | — |
| SECONDARY Urinary Nicotine Equivalents (NEQ) |
5.70; 6.30; 0; 5.13; 7.46; 0 | — |
| SECONDARY Diastolic Blood Pressure |
75.4; 76.6; 72.9; 76.6; 76.6; 77.3 | — |
| SECONDARY Body Weight |
68.44; 66.63; 67.91; 68.13; 66.61; 67.93 | — |
| SECONDARY Waist Circumference |
90.51; 90.30; 91.40; 89.88; 91.01; 93.33 | — |
| SECONDARY Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) |
124.09; 87.34; 0; 39.83; 108.70; 0 | — |
| SECONDARY Total N-nitrosonornicotine (Total NNN) |
3.26; 2.09; 0; 1.39; 2.86; 0 | — |
| SECONDARY 2-cyanoethylmercapturic Acid (2-CyEMA) |
95.38; 98.95; 2.36; 20.21; 111.31; 1.67 | — |
Eligibility Criteria
General 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)
Inclusion criteria specific to patients screened for enrollment and randomization to the CC or IQOS arm:
- 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.
Inclusion Criteria specific to patients screened for enrollment into the SC arm:
- 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.
Data sourced from ClinicalTrials.gov (NCT03837704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.