UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010478
Receipt No. R000012128
Scientific Title Combined Aspirin Study for Mechanical Prosthetic Valve in Kyushu and Ryukyu by Inter-University Hospital Network (ASPIRIN trial)
Date of disclosure of the study information 2013/04/15
Last modified on 2016/10/18

* 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 Combined Aspirin Study for Mechanical Prosthetic Valve in Kyushu and Ryukyu by Inter-University Hospital Network (ASPIRIN trial)
Acronym ASPIRIN trial
Scientific Title Combined Aspirin Study for Mechanical Prosthetic Valve in Kyushu and Ryukyu by Inter-University Hospital Network (ASPIRIN trial)
Scientific Title:Acronym ASPIRIN trial
Region
Japan

Condition
Condition Valvular heart disease
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of thromboembolic and hemorrhagic events between Japanese patients with mechanical prosthetic valve treated by warfarin alone and those treated by combined warfarin and aspirin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Atherosclerotic events, including stroke, TIA, ischemic heart disease, systemic embolism, peripheral artery disease, and valve thrombosis.
2) Cardiovascular death
Key secondary outcomes 1) All cause death
2) Hemorrhagic events, including intracranial bleeding, gastrointestinal bleeding, bleeding requiring hospitalization and/or blood transfusion, and other significant bleeding
3) gastroduodenal ulcer

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria were implantation of a mechanical prosthetic valve, age over 20 years, and provided informed consent.
Key exclusion criteria 1) Contraindications to anticoagulant therapy
2) Pregnant patients
3) Feeding patients
4) Patients who were considered not adequate to be included in the study by an attending physician
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Otsuji
Organization University of Occupational and Environmental Health, Japan, School of Medicine
Division name The Second Department of Internal Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan
TEL 093-603-1611
Email otsujiy@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Tsuda
Organization University of Occupational and Environmental Health, Japan, School of Medicine
Division name The Second Department of Internal Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan
TEL 093-691-7250
Homepage URL
Email yoshimikamio@med.uoeh-u.ac.jp

Sponsor
Institute Yutaka Otsuji
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 大分大学医学部附属病院(大分県)、鹿児島大学医学部・歯学部附属病院(鹿児島県)、九州大学医学部附属病院(福岡県)、熊本大学医学部附属病院(熊本県)、久留米大学病院(福岡県)、佐賀大学医学部附属病院(佐賀県)、産業医科大学病院(福岡県)、長崎大学附属病院(長崎県)、福岡大学病院(福岡県)、宮崎大学附属病院(宮崎県)、琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 15 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 No longer recruiting
Date of protocol fixation
2013 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) non-randomized prospective observational study
2) Selection of treatment (warfarin alone therapy (W group) or warfarin + low dose aspirin therapy (W + A group)) was left to the attending physicians, who were informed that either treatment allowed.
3) Anticoagulant therapy
The daily dose of warfarin was based on the PT-INR. The target PT-INR level was 1.6 to 3.0. PT-INR will be measured every 2 to 4 weeks after hospital discharge.
4) Anti-platelet therapy
Patients of W + A group will receive 100mg of aspirin per day orally.
5) Follow-up
The patients will be monitored routinely for outcome events during hospitalization and during follow-up at 6 months and 1, 2, 3, 4, 5 years postoperatively.

Management information
Registered date
2013 Year 04 Month 12 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.