UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020692 |
|---|---|
| Receipt number | 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 07:35:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kimura@z7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023874
