UMIN-CTR Clinical Trial

Public title

Exploratory study on the cardiovascular system of DPP-4 inhibitors in angina patients underwent PCI after complicated with type 2 diabetes

Acronym

Exploratory study on the cardiovascular system of DPP-4 inhibitors in angina patients underwent PCI after complicated with type 2 diabetes

Scientific Title

Exploratory study on the cardiovascular system of DPP-4 inhibitors in angina patients underwent PCI after complicated with type 2 diabetes

Scientific Title:Acronym

Exploratory study on the cardiovascular system of DPP-4 inhibitors in angina patients underwent PCI after complicated with type 2 diabetes

Region

Japan

Condition

Type 2 diabetic patients with angina pectoris who undergo percutaneous coronary intervention

Classification by specialty

Cardiology

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This is an exploratory study of DPP-4 inhibitor aiming to evaluate the co-relationship between plasma glucose reduction and the change of plaque volume and virtual histology of non-target vascular wall in type 2 diabetic patients with angina.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

1) The change of HbA1 at baseline and 8months after DPP-4 inhibitor treatment.
2) The change of plaque volume of non-culprit lesion at 8 months after PCI.
3) The change of virtual histology of non-culprit lesion segment at 8 months after PCI.
4) The co-relationship between HbA1c redaction and the change of plaque volume

Key secondary outcomes

1) Plasma glucose
2) Serum lipids
3) Peripheral blood CD-34 positive cells
4) High sensitive CRP
5) BNP
6) Blood pressure
7) Body weight
8) Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

DPP-4 inhibitor

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

Age-lower limit

30

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Type 2 diabetes mellitus (HbA1c: 7.0-9.0%)
2) Patients treated PCI
3) Written consent for participation in this study
4) Patients with the age between 30-80 years old male and female at the written consent

Key exclusion criteria

1) Type 1 diabetes mellitus
2) Severe diabetic ketosis, diabetic coma or total coma within 6 months
3) Patients who have 90% or more of the stenosis without PCI culprit lesion
4) Undergoing hemodialysis
5) Severe infectious disease ,before or after surgery, and sever trauma
6) Occurrence of ischemic stroke, hemorrhagic stroke or TIA within 6 months
7) Moderate or severe heart failure (NYHA III or IV)
8) Patients who did not receive DPP4 inhibitors during 3 month before starting study
9) Under treatment with insulin
10) Pregnant,lactating, possibly pregnant or planning to become pregnant women
11) Past medical history of hypersensitivity to linagliptin
12) Patients considered as inadequate by the principal investigator

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Seiji Yamazaki

Organization

Center for Clinical and Biomedical Research,Sapporo Higashi Tokushukai Hospital

Division name

Cardiovascular Research Department

Zip code

Address

14-3-1, Kita 33-jyo Higashi, Higashi-ku, Sapporo, Hokkaido

TEL

011-722-1110

Email

kenkyu@tohtoku.jp

Name of contact person

1st name
Middle name
Last name	kiyotaka takeda

Organization

Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital

Division name

Clinical Research

Zip code

Address

14-3-1, Kita 33-jyo Higashi, Higashi-ku, Sapporo, Hokkaido

TEL

011-722-5820

Homepage URL

Email

yakyoku@higashi-tokushukai.or.jp

Institute

Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人 徳洲会 札幌東徳洲会病院（北海道）

Date of disclosure of the study information

2013

Year

07

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

07

Month

03

Day

Date of IRB

Anticipated trial start date

2013

Year

07

Month

08

Day

Last follow-up date

2016

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

08

Day

Last modified on

2016

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012496