UMIN-CTR Clinical Trial

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	Enrolling by invitation
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	2021 Year 04 Month 30 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	2020 Year 11 Month 12 Day

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