Unique ID issued by UMIN | UMIN000007255 |
---|---|
Receipt number | R000008557 |
Scientific Title | Effect of DPP-4(dipeptidyl peptidase-4) inhibitor for coronary plaque in diabetes patients. |
Date of disclosure of the study information | 2012/02/09 |
Last modified on | 2014/09/09 15:15:45 |
Effect of DPP-4(dipeptidyl peptidase-4) inhibitor for coronary plaque in diabetes patients.
Effect of DPP-4 inhibitor for coronary plaque in diabetes patients.
Effect of DPP-4(dipeptidyl peptidase-4) inhibitor for coronary plaque in diabetes patients.
Effect of DPP-4 inhibitor for coronary plaque in diabetes patients.
Japan |
Ischemic Heart Disease,Diabetes Mellitus
Cardiology | Endocrinology and Metabolism |
Others
NO
To compare the effect of glimepiride or vildagliptin for coronary plaque in one-year after the percutaneous coronary intervention in diabetes patients.
Efficacy
Exploratory
Change in coronary plaque volume
1)Change in coronary plaque character by IB-IVUS (integrated backscatter intravascular ultrasound).
2)HbA1c,BS,TG,LDL-CHO,HDL-CHO.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Medicine |
In vildagliptin group,patients will be administered vildagliptin 100mg/day in one-year after the percutaneous coronary intervention.
In glimepiride group,patients will be administered glimepiride 1-4mg/day in one-year after the percutaneous coronary intervention.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who underwent stent implantation for coronary heart disease.
2) Type2 diabetes mellitus with HbA1c level of 6.0% to 9.0% (if taking a glucose-lowering medication) or 6.5% to 10% (if not currently receiving drug therapy).
1)Patients with severe coronary stenosis who are eligible for IVUS.
2)Acute myocardial infarction
3)Patients who have unprotected LMT lesion.
4)Severe renal disease or/and serum creatinine level>2.0mg/dl
5)Left ventricular ejection fraction=<40%
6)Type1 diabetes mellitus
7)Allergy for antiplatelet,anticoagulant drug,dipeptidyl-peptidase4 inhibitor and sulfonylureas
8)Severe liver dysfunction
9)Pregnancy
10)Other patients judged as being inappropriate for the subjects of the study by investigators.
128
1st name | |
Middle name | |
Last name | Yoshio Kobayashi |
Chiba University Hospital
Center for Cardiovascular Interventions
1-8-1 Inohana,Chuo-ku,Chiba City
043-222-7171
yoshio.kobayashi@wonder.ocn.ne.jp
1st name | |
Middle name | |
Last name | Keiichiro Miura |
Chiba University Hospital
Center for Cardiovascular Interventions
1-8-1 Inohana,Chuo-ku,Chiba City
043-222-7171
markone@hospital.chiba-u.jp
Center for Cardiovascular Interventions,Chiba University Hospital
Center for Cardiovascular Interventions,Chiba University Hospital
Self funding
NO
2012 | Year | 02 | Month | 09 | Day |
Unpublished
Terminated
2011 | Year | 10 | Month | 26 | Day |
2011 | Year | 10 | Month | 26 | Day |
2014 | Year | 06 | Month | 30 | Day |
2014 | Year | 06 | Month | 30 | Day |
2014 | Year | 06 | Month | 30 | Day |
2012 | Year | 02 | Month | 09 | Day |
2014 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008557
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |