UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between anti-Xa activity and the renal function in elderly patients who are on apixaban
Title of the study (Brief title)	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	Seiji Takatsuki
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	0333531211
Email	seiji.takatsuki@gmail.com

Public contact
Name of contact person	Takehiro Kimura
Organization	Keio University School of Medicine
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023874