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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020692
Receipt No. R000023874
Scientific Title The relationship between anti-Xa activity and the renal function in elderly patients who are on apixaban
Date of disclosure of the study information 2016/04/01
Last modified on 2017/07/24

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Basic information
Public title The relationship between anti-Xa activity and the renal function in elderly patients who are on apixaban
Acronym The relationship between anti-Xa activity and the renal function in elderly patients who are on apixaban
Scientific Title The relationship between anti-Xa activity and the renal function in elderly patients who are on apixaban
Scientific Title:Acronym The relationship between anti-Xa activity and the renal function in elderly patients who are on apixaban
Region
Japan

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

Objectives
Narrative objectives1 This study was intended to evaluate the anti-Xa activity in association with the serum concentration of the drug in order to reveal the pharmacokinetics in elderly patients aged 70 years or older. We aimed to elucidate the safety of the drug focusing on the renal function in elderly patients who are on apixaban (Eliquis), which is suggested to be "safely administrable even in the elderly" by large-scale clinical studies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The confounding factors for affecting the anti-Xa activity and serum concentration.
Key secondary outcomes

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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients aged 70 years or older who are on apixaban for the prevention of ischemic strokes and systemic embolisms in patients with nonvalvular AF
Key exclusion criteria Patients contraindicated for apixaban
(1)Patients with a history of a hypersensitivity to the ingredients of apixaban
(2)Patients with bleeding symptoms which can be of a clinical concern within 6 months (e.g., active gastric ulcers, platelets < 100000, hemoglobin < 10 g/dL, and s stroke within 10 days)
(3)Patients with blood clotting defects and liver disease with a clinically important bleeding risk
(4)Patients with renal failure (creatinine clearance < 15 mL/min)
Severe liver dysfunction (AST and ALT of > 2-fold the upper limits of normal (ULN) and a total bilirubin of > 1.5-fold the ULN)
Patients with valvular disorders requiring surgery
Patients who cannot orally take drugs or visit the Outpatient Unit on a regular basis
Patients with a prognosis of < one year
Patients anticoagulated with heparin or enoxaparin
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
TEL 0333531211
Email seiji.takatsuki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Kimura
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL 0333531211
Homepage URL
Email kimura@z7.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 04 Month 01 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 Terminated
Date of protocol fixation
2015 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: Cohort
Recruitment: Patients who matched the inclusion criteria since 2016/6.
Measurements: The anti-Xa activity, trough concentration, other coagulation markers (Xa activity, D-dimer, Protein C, prothrombin fragment F1 + 2, activated partial thromboplastin time, and prothrombin time), a questionnaire to check the treatment compliance

Management information
Registered date
2016 Year 01 Month 21 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023874

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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