UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027224 |
|---|---|
| Receipt number | R000029784 |
| Scientific Title | The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients. |
| Date of disclosure of the study information | 2017/05/02 |
| Last modified on | 2018/11/15 11:58:52 |
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Basic information
Public title
The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Acronym
The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Scientific Title
The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Scientific Title:Acronym
The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of Teneligliptin on vascular inflammatory markers in PCI patients with T2DM (Type 2 diabetes mellitus).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variation amount and rate of inflammatory markers from pretreatment levels.
Key secondary outcomes
Vascular endothelial function: RH-PAT score, variation amount and rate of HbA1c, and glucose from pretreatment levels.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Additional treatment of Teneligliptin
Interventions/Control_2
Conventional treatment
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Elective PCI patients
2)Patients who have T2DM and HbA1c (NGSP) level are more than 7% before PCI
3)Patients aged 30 up to 80 years old
4)Informed consent was signed by all patients and documented.
Key exclusion criteria
1)Patients with T1DM (type 1 diabetes mellitus)
2)Patients who have medical history of hypersensitivity to diabetes mellitus drugs
3)Patients with medical history of malignant tumor
4)Patients with severe infection, before and after operation, or severe trauma
5)Patients with cardiac arrest (class of III in NYHA)
6)Patients with uncontrolled hypertension 7)Patients with insulin dependent and the potential to change diabetic drugs
8)Patients with severe renal insufficiency
(eGFR is less than 30 mL / min / 1.73 m2, dialysis-dependent, or serum creatinine (men, more than 2.5 mg / dL, women, more than 2.0 mg / dL
9) Patients with pregnant, and possibly pregnant
10) Patients with severe ketosis, diabetic coma, or history of coma within the past six months
11)Patients who had stroke, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack within the past three months.
12)Patients who enrolled into another clinical test within three months prior to this trial
13)Patients who cannot administer antiplatelet drugs
14)Patients who were considered as inappropriate for the study by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Matshumura |
Organization
Kameda Medhical Center
Division name
Department of Cardiology
Zip code
Address
929 Higashi-cho Kamogawa City CHiba
TEL
04-7092-2211
matsumura.akihiko@kameda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya JUNI |
Organization
AsMediX Co., Ltd.
Division name
GPO Department , Business Planning Section
Zip code
Address
Higashiazabu 1-5-2, Minato-ku, Tokyo
TEL
03-6230-3661
Homepage URL
aya_juni@asmedix.co.jp
Sponsor or person
Institute
Kameda Medhical Center
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
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
| 2017 | Year | 05 | Month | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 02 | Day |
Last modified on
| 2018 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029784
