UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy and safety of Dabigaran in patients with catheter ablation for atrial fibrillation.
Title of the study (Brief title)	Evaluation of efficacy and safety of Dabigaran during catheter ablation
Region	Japan

Condition
Condition	Atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety of Dabigaran in patients with catheter ablation for atrial fibrillation: comparison with those of Warfarin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cerebral bleeding and stroke, systematic embolism, bleeding complication
Key secondary outcomes	Abnormal finding in blood test

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients with symptomatic paroxysmal or persistent atrial fibrillation and no valvular diseases.
Key exclusion criteria	Patients with chronic atrial fibrillation, valvular heart diseases, severe renal dysfunction, history of allergy of this drug, bleeding tendency, high risk of bleeding, subdural catheter, and antithrombotic drugs.
Target sample size	140

Research contact person
Name of lead principal investigator	Minoru Yoshiyama
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Internal Medicine and Cardiology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3801
Email	yoshiyama@med.osaka-cu.ac.jp

Public contact
Name of contact person	Kiyoko Ogino
Organization	Osaka City University Hospital
Division name	Department of ethics
Address	1-5-7 Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3439
Homepage URL
Email	ethics@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

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

Other related organizations
Co-sponsor	Baba Memorial Hospital Ishikiri Seiki Hospital Kansai Medical College Hirakata Hospital Matsue Seikyo Hospital
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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 05 Month 31 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2014 Year 12 Month 31 Day
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	We are going to recrute patients.

Management information
Registered date	2013 Year 07 Month 18 Day
Last modified on	2017 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013150