UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007340
Receipt No. 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 (Ver. 5)

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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
Email 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
Email kcvc.nakamura@katsura.com

Sponsor
Institute Association of Kansai Cardiovascular Treatment Study
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008517