UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007340 |
|---|---|
| Receipt number | R000008517 |
| Scientific Title | Sitagliptin Acute Coronary Syndrome Randomised Investigation Registry |
| Date of disclosure of the study information | 2012/02/24 |
| Last modified on | 2019/07/17 18:58:30 |
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Basic information
Public title
Sitagliptin Acute Coronary Syndrome Randomised Investigation Registry
Acronym
SAMURAI-REGISTRY
Scientific Title
Sitagliptin Acute Coronary Syndrome Randomised Investigation Registry
Scientific Title:Acronym
SAMURAI-REGISTRY
Region
| Japan |
Condition
Condition
acute coronary syndrome requiring coronary stent implantation in patients with type 2 diabetes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the inhibitory effect of blood lowering therapy with DPP-4 Inhibitor on the neointimal formation and progression of arteriosclerosis in high-risk type-2 diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Key secondary outcomes
intimal thickness at 8 months evaluated by IVUS, OCT and carotid vascular echography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For Type 2 diabetic patients (HbA1c level: 6.5%-9.0%) with acute coronary syndrome, who had undergone coronary intervention with bare metal stent (Liberte; Coronary Stent System), Sitagliptin Phosphate Hydrate (DPP-4 Inhibitor) is initiated at a dose of 50mg per day post stenting and titrated up as needed to 100mg per day to reach the target level of HbA1c within 6.5%. Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 8 months will be estimated. Estimation of arteriosclerosis is examined at baseline and at 8 months by imaging diagnostics modalities (coronary angiography, IVUS, OCT, and carotid vascular echography).
Interventions/Control_2
For Type 2 diabetic patients (HbA1c level: 6.5%-9.0%) with acute coronary syndrome, who had undergone coronary intervention with bare metal stent (Liberte; Coronary Stent System), conventional antidiabetic agent is initiated to reach the target level of HbA1c within 6.5%. Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 8 months will be estimated. Estimation of arteriosclerosis is examined at baseline and at 8 months by imaging diagnostics modalities (coronary angiography, IVUS, OCT, and carotid vascular echography).
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with acute coronary syndrome, who had undergone percutaneous coronary intervention with bare metal stent (Liberte; Coronary Stent System)
2)Patients, whose left main trunk or the other coronary stem than ostial of each coronary artery are treated.
3)Patients who are treated with single stent.
4)Patients who are treated with the under 3.5mm sized stents.
5)Patients who fit one of following three cases, as well as who are diagnosed as type 2 diabetic patients of not being well controlled.*
*Type 2 diabetic patients whose latest HbA1c are above 6.5%, under 9.0%.
*Type 2 diabetic patients who have above 126mg/dl in their interdigestive rate or above 200mg/dl in the rate after 2 hours of glucose tolerance test or regularly.
*Type 2 diabetic patients who has been already taking diabetes drug, and 5.8% above in HbA1c. (= well controlled HbA1c)
6)Patients over 20 years old, under 80 years old.
7)Patients with written agreements.(signed contracts)
Key exclusion criteria
1)Type 1 diabetic patients
2) Patients who have histories of serious ketosis, diabetic coma or entire coma within 6 months.
3)Patients with serious infections, or before and after the operations, or who have serious/critical external injuries.
4)Patients with moderate to severe renal insufficiency.
(serum creatinine level: 1.5mg/dL or above (male), 1.3mg/dL or above (female)
5)Patients with serious/critical valve diseases such as mitral stenosis or aortic regurgitation.
6)Patients who are prescribed some DPP-4 inhibitory drug other than Sitagliptin.
7)Patients who are continuously prescribed glinide and insulin, when the researching drug (Sitagliptin) is administered.
8)Patients of over 140mg/dL in their LDL-C rates.
9)Women during lactation, pregnant women and women suspected of being pregnant
10)Patients who have histories of hypersensitivity to researching drug.
11)Patients who are not available for administration of anti-thrombotic medicines.
12)Any other patients who are evaluated as inappropriate by the doctor in attendance.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kinzo |
| Middle name | |
| Last name | Ueda |
Organization
Rakuwakai Marutamachi Hospital
Division name
Kyoto Cardiovascular Intervention Center
Zip code
604-8401
Address
9 Kurumazaka-cho Nishinokyo Nakagyo-ku Kyoto
TEL
075-801-0351
kin-ueda@mbc.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Nakamura |
Organization
Kyoto Katsura Hospital
Division name
Cardiovascular Center
Zip code
615-8256
Address
17 Yamadahirao-cho Nishikyo-ku Kyoto
TEL
075-382-3185
Homepage URL
kcvc.nakamura@katsura.com
Sponsor or person
Institute
Association of Kansai Cardiovascular Treatment Study
Institute
Department
Personal name
Funding Source
Organization
Regional Medical Research Fund
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Katsura Hospital
Address
17 Yamadahirao-cho Nishikyo-ku Kyoto
Tel
075-382-3185
kcvc.nakamura@katsura.com
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
洛和会丸太町病院（京都府）、京都桂病院（京都府）、康生会武田病院（京都府）、医仁会武田総合病院（京都府）、草津ハートセンター（滋賀県）、近江八幡市立総合医療センター（滋賀県）、神戸大学大学院医学研究科（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000008517
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000008517
Number of participants that the trial has enrolled
32
Results
Because of Supply (Liberte stent) stop, this study was ended on the half way.
Results date posted
| 2019 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Total 32cases were entered.Conventional therapy 12cases,Sitagliptin 20cases.
Participant flow
2012.3.5 Entry start.
2015.8.2 Last entry
Adverse events
Nothing
Outcome measures
No results.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008517
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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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