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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033844
Receipt No. 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

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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
Email -@-

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
Email matumoto.takuyuki.y2@daiichisankyo.co.jp

Sponsor
Institute DAIICHI SANKYO CO., LTD.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038599

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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