UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010478 |
|---|---|
| Receipt number | 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 | 2021/10/21 21:19:23 |
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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
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
yoshimikamio@med.uoeh-u.ac.jp
Sponsor or person
Institute
Yutaka Otsuji
Institute
Department
Personal name
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
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
| 2012 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012128
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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