UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection
Acronym	Prophylactic administration of diltiazem for atrial fibrillation after lung resection
Scientific Title	Phase II study of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection
Scientific Title:Acronym	Prophylactic administration of diltiazem for atrial fibrillation after lung resection
Region	Japan

Condition
Condition	atrial fibrillation after lung resection
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection (inhibition ratio of onset)
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of atrial fibrillation after lung resection
Key secondary outcomes	Degree and frequency of adverse event (hypotension, bradycardia, etc.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Diltiazem 90mg/day from POD 1 to POD 7 Diltiazem 60mg/day from POD 8 to POD 14
Interventions/Control_2	Lactose 0.9g/day from POD 1 to POD 7 Lactose 0.6g/day from POD 8 to POD 14
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	45 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	primary lung cancer lobectomy or pneumonectomy PS 0-2 be able to take something by mouth WBC >3000 Hb >9.5 Plt >100000 T-bil <1.5 AST, ALT <80 Cre <1.5 PaO2 >65 or SpO2 >92 informed consent
Key exclusion criteria	unstable angina pectoris, myocardial infarction or heart failure with in 3 months uncontrolled diabetes or hypertension active infection gastrointestinal bleeding diarrhea ileus chronic Af already taking diltiazem or other calcium blocker AV block more than 2nd degree sick sinus syndrome past history of severe allergy uncontrolled pleural effusion, ascites or pericardial fluid in pregnancy
Target sample size	124

Research contact person
Name of lead principal investigator	1st name Middle name Last name Satoshi Kondo
Organization	Hokkaido University Hospital
Division name	Surgery II
Zip code
Address	North 14 West 5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Email

Public contact
Name of contact person	1st name Middle name Last name Yasuhiro Hida
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Surgical Oncology
Zip code
Address
TEL	011-706-7714
Homepage URL
Email

Sponsor
Institute	Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Teine Keijinkai Hospital Minami Sanjo Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2009 Year 02 Month 06 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	2008 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 02 Month 06 Day
Last modified on	2010 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002035

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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