UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033844 |
|---|---|
| Receipt number | R000038599 |
| Scientific Title | Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin) |
| Date of disclosure of the study information | 2018/08/21 |
| Last modified on | 2020/03/03 13:57:22 |
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Basic information
Public title
Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin)
Acronym
Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin)
Scientific Title
Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin)
Scientific Title:Acronym
Bleeding risk assessment of anticoagulation therapy in patients with both ischemic heart disease and atrial fibrillation after Percutaneous Coronary Intervention (comparison between direct oral anticoagulants and Warfarin)
Region
| Japan |
Condition
Condition
Ischemic heart disease (IHD) and non-valvular atrial fibrillation (NVAF), undergone PCI with stent implantation
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety events (bleeding) in patients with IHD and NVAF after PCI with stent implantation and treated with direct oral anticoagulants (DOAC) or Warfarin (Vitamin K Antagonist).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Initial bleeding event observed during the follow-up period (any of the events from i to v below)
i) Bleeding requiring blood transfusion
ii) Intracranial bleeding
iii) Intraocular bleeding
iv) Upper gastrointestinal bleeding
v) Lower gastrointestinal bleeding
Key secondary outcomes
(1) Initial bleeding event observed during the follow-up period (each of the events from i to v described in the "primary outcomes" section)
(2) All initial bleeding events observed during the follow-up period
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All of the following criteria are satisfied (Patients who have undergone PCI which satisfies all of the following criteria are included)
-Underwent PCI between April 1, 2012 and May 31, 2017
-Diagnosed as both NVAF and IHD between 2 months before PCI and 1 month after PCI
-Received dual antiplatelet therapy on the next day and 2 days after PCI
-Prescribed DOAC or VKA from 1 to 7 days after PCI
Key exclusion criteria
Any of the following criteria is satisfied (Patients who have undergone PCI which satisfies the key inclusion criteria but all of whose PCIs satisfy any of the following criteria are excluded)
-17 years of age or younger at the time of PCI
-The follow-up started on or after June 1, 2017
-Prescribed both DOAC and VKA from 1 to 7 days after PCI
-Not prescribed either thienopyridine antiplatelet agent or aspirin continuously at the start of follow-up. (All of the three components, i.e. anticoagulant, thienopyridine platelet agent, and aspirin, are not prescribed concomitantly.)
The start of follow-up must be within the period of continuous prescription excluding grace period to judge that "the patient is continuously prescribed them at the start of follow-up."
-The record of the date of PCI is the last record.
We do not set the target sample size. All the patients who meet the key inclusion criteria and do not meet the key exclusion criteria are potential participants for this study.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyuki Arai |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Safety and Risk Management Department
Zip code
Address
3-5-1 Nihonbashi-honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL
03-6225-1192
-@-
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuyuki Matsumoto |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Safety and Risk Management Department
Zip code
Address
3-5-1 Nihonbashi-honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL
03-6225-1192
Homepage URL
matumoto.takuyuki.y2@daiichisankyo.co.jp
Sponsor or person
Institute
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
CLINICAL STUDY SUPPORT, INC.
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
| 2018 | Year | 08 | Month | 21 | 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
5695
Results
The incidence of primary outcome events (clinically relevant bleeding/100 PY, 95% CI) was 6.05 (5.01, 7.32) in the DOAC group and 8.42 (6.96, 10.19) in the VKA group. The adjusted HR (95% CI) in the DOAC group relative to the VKA group was 0.79 (0.60, 1.04) .
Results date posted
| 2020 | Year | 03 | Month | 03 | Day |
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study using a medical claims database
Management information
Registered date
| 2018 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038599
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| Registered date | File name |
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