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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035516
Receipt No. R000040452
Official scientific title of the study 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.
Date of disclosure of the study information 2019/01/11
Last modified on 2019/01/11

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Basic information
Official scientific title of the study 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.
Title of the study (Brief title) Comparison AAA growth in adult smoking patients who either switch to IQOS, continue smoking, or had stopped smoking.
Region
Japan

Condition
Condition Abdominal Aortic Aneurysm
Classification by specialty
Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the reduction in the AAA annual growth rate in patients who switch from smoking cigarettes (CC) to using IQOS, as compared to patients who continue to smoke CC (IQOS arm versus cigarette arm), also as compared to patients who had stopped smoking (IQOS arm versus SC arm), and to evaluate the reduction in the AAA annual growth rate in patients who continue to smoke CC as compared to patients who had stopped smoking (CC arm versus SC arm).
Basic objectives2 Others
Basic objectives -Others 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.
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes (Endpoints for evaluation concerning Narrative objective1 )
・ Measurement of the maximum minor-axis AAA diameter in mm
・ AAA annual growth rate
Key secondary outcomes To describe or evaluate the following outcomes in patients who switch from smoking CC to using IQOS, as compared to patients who continue smoking CC and patients who had stopped smoking. (Following 1-5):
1 Date of diagnosis/ decision to perform open surgical AAA treatment or AAA endovascular repair/ Date of AAA rupture
2 Number of patients with open surgical AAA treatment or AAA endovascular repair annually / Number of patients with AAA rupture annually
3 Number of patients with an increase in maximum minor-axis AAA diameter of more than 5 mm within 6 months/Number of patients with an overall maximum minor-axis AAA diameter >55mm in male patients and >50mm in female patients
4 The progression of AAA: See endpoints of secondary objectives and endpoints No 1 to No. 3.
5 Annual incidence of Ischemic Heart Disease(IHD), IHD progression or IHD related events/ of Chronic Obstructive Pulmonary Disease(COPD), COPD progression or a COPD related events/ of hypertension, progression of hypertension, progression of hypertension or a hypertension related events/ of Peripheral Arterial Disease(PAD), PAD progression or PAD related events/ of other smoking-related diseases and their related events.

6. Safety profiles

To describe about following outcomes in AAA patients who switch from smoking CC to using IQOS, patients who continue to smoke CC, and patients who had stopped smoking. (Following 7,8):
7. Nicotine exposure over time: Nicotine equivalents (NEQ)
8. Cardiovascular CREs/ BoExp to selected HPHCs

9. To describe the ankle-brachial index over time in AAA patients who switch from smoking CC to using IQOS, patients who continue to smoke CC, and patients who had stopped smoking.

10. To evaluate the transcriptomic, proteomic and lipidomic profiles in patients switching from CC to IQOS as compared to those continuing to smoke CC and patients who had stopped smoking.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 IQOS arm: AAA patients randomized to the IQOS arm will be instructed to use exclusively IQOS ad libitum over the entire study period (no flavor restrictions).
Interventions/Control_2 Cigarette arm: AAA patients randomized to the cigarette arm will be instructed to continue smoking their cigarettes ad libitum over the entire study period (no brand restrictions).
Interventions/Control_3 Adults who had stopped smoking (as a non-randomized control arm): Patients who had completely quitted smoking within 2 months after their AAA diagnosis and are allocated to the SC arm, are instructed to refrain entirely from the use of any tobacco or nicotine-containing tobacco product (except nicotine replacement therapy [NRTs]) during the Investigational Period.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patient is aged >=50years
2.Patient is Japanese
3.Patient diagnosed with AAA(infrarenal,fusiform type)with a current aortic maximum minor-axis diameter of 30 to <=49mm(in male patient)and 30 to <=44mm(in female patient)
a)Diagnosis of AAA within the past 30months with at least two computerized tomography assessments since diagnosis. The two CT scans must show a time difference of at least 6months in between measurements
b)The maximum minor-axis AAA diameter to be used for assessment of eligibility is the maximum minor-axis AAA diameter available at the time of enrollment
4.Patient has smoked on average at least 10 commercially available CC per day for at least 5years prior to AAA diagnosis,based on self-reporting
5.Patient is ready to comply with the study protocol
Specific to patients screened for enrollment and randomization to the CC or IQOSarm: Seventy-six(76)female or male Japanese adult smokers with diagnosed AAA meeting the following additional main inclusion criteria will be enrolled and randomized in the CC and IQOSarm of the study:
6.Patient has smoked on average at least 10 commercially available CC per day for the last 12months,based on self-reporting. Intermittent attempts to quit smoking not exceeding 2months or short-term interruption of smoking up to 10days within the last 12months will be allowed. Smoking status will be verified based on a urinary cotinine test
7.Not intending to quit smoking within the next 6months after having been advised to quit smoking
Specific to patients screened for enrollment into the SCarm:
Thirty-eight female or male Japanese adult patients with diagnosed AAA meeting the following additional main inclusion criteria will be enrolled in the SCarm of the study:
8.Patient had completely quitted smoking and stopped the use of any other tobacco or nicotine-containing products within 2months after AAA diagnosis,and is still abstinent at Screening and at Baseline. Smoking status will be verified based on a urinary cotinine test
Key exclusion criteria 1. Patient is legally incompetent, physically or mentally incapable of giving consent.
2. Patient with acute severe cardiovascular events or respiratory diseases, within the last 3 months.
3. Patient with currently active cancer or history of cancer within the last 5 years.
4. Patient is ineligible as judged by the Investigator to participate in the study for any reason.
5. Patient with dissecting aneurysm(s) of the aorta.
6. Patient with infrarenal pseudo-AAA (false AAA).
7. Patient with a diagnosis of COPD Stage 3 and 4 in the medical history.
8. Patient with a recent (within 1 year) or current history of alcohol or other substance abuse based on self-reporting.
9. Female patient who is pregnant or breast-feeding.
10. 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.
11. Patient is a current or former employee of the tobacco industry or their first-degree relatives (parent and child).
12. Patient is an employee of the investigational site or any other parties involved in the study or their first-degree relatives (parent and child).
13. Patient has been previously screened or enrolled in this study).
14. Patient was enrolled in any clinical study within 3 months prior to V1.
Target sample size 114

Research contact person
Name of lead principal investigator Takeshi Baba
Organization Jikei University Hospital
Division name Division of vascular surgery
Address 3-19-18, Nishishinbashi, Minato-ku, Tokyo, 105-8471, JAPAN
TEL +81-3-3433-1111
Email takeshi-baba@live.jp

Public contact
Name of contact person Ryoko Ohara
Organization CMIC Co., Ltd.
Division name Project Management Division
Address Hamamatsucho Building 1-1-1 Shibaura,Minato-ku,Tokyo 105-0023 Japan
TEL +81-70-6486-2991
Homepage URL
Email ryoko-ohara.yp@cmic.co.jp

Sponsor
Institute Philip Morris Products S.A.
Institute
Department

Funding Source
Organization Philip Morris Products S.A.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Switzerland

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 新百合ヶ丘総合病院 (神奈川県)/ AOI国際病院(神奈川県)/ 埼玉県立循環器・呼吸器病センター(埼玉県)/ 厚木市立病院(神奈川県)/ 湘南鎌倉総合病院 (神奈川県)/ Shin Yurigaoka Hospital (Kanagawa Prefecture)/ AOI University Hospital (Kanagawa Prefecture) / Saitama Cardiovascular and Respiratory Center (Saitama Prefecture)/ Atsugi City Hospital (Kanagawa Prefecture)/ Shonan Kamakura General Hospital (Kanagawa Prefecture)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 11 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 25 Day
Anticipated trial start date
2018 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 11 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040452

Research Plan
Registered date File name

Research case data specifications
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Research case data
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