UMIN-CTR Clinical Trial

Basic information
Public title	Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Acronym	Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Scientific Title	Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Scientific Title:Acronym	Prescription of Direct Oral Anticoagulant Affects Activated Clotting Time During Percutaneous Coronary Intervention and Bleeding Events
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to evaluate the changes of activated clotting time during percutaneous coronary intervention (PCI)and adverse clinical events after PCI in patients who were prescribed direct oral anticoagulant
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Prognosis from the end of percutaneous coronary revascularization to 30 days (bleeding events, embolic events)
Key secondary outcomes	Kinetic changes in activated coagulation time during percutaneous coronary revascularization (at the start and 30 minutes after the procedure)

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	Patients who underwent PCI in the cardiovascular centers in Japan between February 2017 and April 2018.
Key exclusion criteria	Patients receiving warfarin at the time of percutaneous coronary intervention (PCI) and patients whose activated clotting time was not measured at the time of PCI initiation were excluded.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Jujo
Organization	Tokyo women medical university
Division name	Department of Cardiology
Zip code	162-0054
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL	81-3-3353-8111
Email	juken1123@mac.com

Public contact
Name of contact person	1st name Eiji Middle name Last name Shibahashi
Organization	Tokyo Womens Medical University
Division name	Department of Cardiology
Zip code	162-0054
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL	81-3-3353-8111
Homepage URL
Email	shiabahashi.e@gmail.com

Sponsor
Institute	Tokyo women medical university
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nishiarai hospital
Address	1-12-12, Nishiaraihoncho, Adachi-ku, Tokyo, Japan
Tel	03-5647-1700
Email	shiabahashi.e@gmail.com

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	2022 Year 05 Month 30 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	246
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	Completed
Date of protocol fixation	2017 Year 01 Month 01 Day
Date of IRB	2022 Year 01 Month 14 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: cohort study All patients who visited the relevant center between February 2017 and April 2018 and met the selection criteria

Management information
Registered date	2022 Year 05 Month 04 Day
Last modified on	2022 Year 05 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054120