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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032552
Receipt No. R000037129
Scientific Title Effects of smoking cessation on HDL function and cardiovascular biomarkers.
Date of disclosure of the study information 2018/05/11
Last modified on 2019/05/12

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Basic information
Public title Effects of smoking cessation on HDL function and cardiovascular biomarkers.
Acronym Smoking cessation and HDL function
Scientific Title Effects of smoking cessation on HDL function and cardiovascular biomarkers.
Scientific Title:Acronym Smoking cessation and HDL function
Region
Japan

Condition
Condition Nicotine addiction
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test whether varenicline-assisted smoking cessation for 4 weeks affect HDL levels, function, and cardiovascular biomarkers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HDL cholesterol levels, cholesterol efflux capacity/antioxidant activity of HDL
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 varenicline treatment for 4 weeks
Interventions/Control_2
Interventions/Control_3
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Outpatients with nicotine addiction
2) Subjects who gave written informed consent
Key exclusion criteria 1) Poor-controlled hypertension (DBP>110 mmHg)
2) Poor-controlled diabetes (HbA1c>8.0 %)
3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
5) End stage renal disease
6) Symptomatic (NYHA III or IV) congestive heart failure
7) Malignancies or other diseases with poor prognosis
8) Subjects with poor-controlled psychiatric diseases
9) Subjects who are prohibited varenicline treatment
10) Subjects whose doctor in charge do not agree to join the trial
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Ayaori
Organization Tokorozawa Heart Center
Division name Shintikoekimae Clinic
Zip code 3591111
Address 1-4-1-101 Midoricho, Tokorozawa, Saitama JAPAN 359-1111
TEL 0429291801
Email ayaori@ba2.so-net.ne.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ayaori
Organization Tokorozawa Heart Center
Division name Shintikoekimae Clinic
Zip code 3591111
Address 1-4-1-101 Midoricho, Tokorozawa, Saitama JAPAN 359-1111
TEL 0429291801
Homepage URL
Email ayaori@ba2.so-net.ne.jp

Sponsor
Institute Tokorozawa Heart Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokorozawa Heart Center
Address 2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
Tel 04-2940-8611
Email cs.thc@oukai.or.jp

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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 03 Month 07 Day
Date of IRB
2017 Year 03 Month 07 Day
Anticipated trial start date
2018 Year 05 Month 11 Day
Last follow-up date
2020 Year 03 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 11 Day
Last modified on
2019 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037129

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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