UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006907 |
|---|---|
| Receipt number | R000008148 |
| Scientific Title | Anticoagulation therapy around catheter ablation for atrial fibrillation -Dabigatran vs. Warfarin- |
| Date of disclosure of the study information | 2011/12/19 |
| Last modified on | 2012/07/26 13:12:25 |
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Basic information
Public title
Anticoagulation therapy around catheter ablation for atrial fibrillation -Dabigatran vs. Warfarin-
Acronym
DAWN-AF Trial
Scientific Title
Anticoagulation therapy around catheter ablation for atrial fibrillation -Dabigatran vs. Warfarin-
Scientific Title:Acronym
DAWN-AF Trial
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients undergoing catheter ablation for atrial fibrillation will be randomly assigned to Dabigatran or Warfarin anticoagulation therapy groups and the hospitalization period and cost, as well as adverse events will be compared.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total hospitalization period for the perioperative period of atrial fibrillation ablation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dabigatran group
150 mg administered twice daily (2 capsules (75 mg), twice daily)
The dosage should be reduced to 110 mg twice daily, as required.
Interventions/Control_2
Warfarin group
Administer once daily (adjust dosage aiming at a PT-INR [prothrombin time-international ratio] of 2.0 - 3.0). However, for patients aged >= 70 yrs, adjust dosage aiming at a PT-INR of 1.6 - 2.6. Blood samples should initially be collected once weekly until the INR stabilizes and then once monthly. However, many patients enrolled in this study are already taking warfarin. In these patients, blood samples can be collected once monthly only.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those patients who satisfy the following criteria will be eligible for entry to this study.
1. Patients in whom atrial fibrillation ablation is indicated
A) Patients with Symptomatic AF
B)Patients resistant to antiarrhythmic drug
C) Left atrium diameter >= 55 mm
D) No left atrial thrombus
2. Patients age 20-80
3. Patients must be able and willing to provide written informed
Key exclusion criteria
Patients who do not satisfy inclusion criteria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Takatsuki |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5843-6702
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Takatsuki |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5843-6702
Homepage URL
Sponsor or person
Institute
DAWN-AF-Trial Society
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan, Inc.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 12 | Month | 19 | 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
| 2011 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | 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
| 2011 | Year | 12 | Month | 19 | Day |
Last modified on
| 2012 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008148
