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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010093
Receipt No. R000011822
Scientific Title The Effect of Alogliptin on Cardiovascular Disease in Patients with Acute Coronary Syndromes
Date of disclosure of the study information 2013/02/22
Last modified on 2017/09/05

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Basic information
Public title The Effect of Alogliptin on Cardiovascular Disease in Patients with Acute Coronary Syndromes
Acronym The Effect of Alogliptin on Cardiovascular Disease in Patients with Acute Coronary Syndromes
Scientific Title The Effect of Alogliptin on Cardiovascular Disease in Patients with Acute Coronary Syndromes
Scientific Title:Acronym The Effect of Alogliptin on Cardiovascular Disease in Patients with Acute Coronary Syndromes
Region
Japan

Condition
Condition Acute coronary syndromes
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the acute and chronic effects of alogliptin (DPP-4 inhibitor) on coronary plaque characteristics in Patients with acute coronary syndromes and dysglycemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Absolute and normalized plaque volume and percent changes in plaque volume as well as plaque characteristics assessed by IVUS.
Key secondary outcomes *Changes in plaque characteristics including coronary fibrous-cap thickness assessed by OCT,
*Changes in MLD and % stenosis,
*Frequency of periprocedual myocardial infarction,
*Changes in inframmatory markers (hs-CRP, MMP9, IL6, etc) and lipid/glycemic status (including CGM data),
*Changes in endothelial function assessed by Endo-PAT 2000,
*Changes in echographic parameters (cardiac function, IMT etc),
*MRI parameters including LGE, peri/para-cardial fat.
*Changes in oxidative stress markers,
*Prognosis (death, ACS, heart failure, restenosis, stroke, etc),
*Changes in ABPM parameters, ectopic fat assessed by Abdominal CT and DEXA.


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Alogliptin treatment;
Additional treatment with alogliptin 25mg/day for 10+or-2 months (study period).
Glycemic control goal (target HbA1c levels):6.5%/JDS (6.9%/NGSP).
Interventions/Control_2 Treatment without alogliptin (other DPP-4 inhibitors or GLP-1 analogues);
Glucose lowering therapy without DPP-4 inhibitors/GLP-1 analogues in the study period.
Glycemic control goal (target HbA1c levels):6.5%/JDS (6.9%/NGSP).
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with acute coronary syndrome (defined as ST-segment elevation acute myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina). Patients who meet at least two of the following criteria within 28 days prior to admission:
1. ECG changes of acute coronary ischemia
2. Serum CK level more than 2 times the upper limit of normal, serum CK-MB or troponin (T/I) over the above upper limit of normal, or positivity for serum troponin T or I by a rapid, qualitative assay
3. Clinical history or evident pphysiological findings of acute coronary syndromes.
2) Patients who have at least one coronary plaque of 25% diameter stenosis or more in the culprit vessel, the target plaque needs to be 5 mm or more depart from the culprit lesion for PCI, or at the non-culprit lesion/vessels).
3) Patinets with dysglycemia defined by the criteria of the Japanese Diabetes Society.
4) Patients 20 years old or older at the time of consent.
5) Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study.

Key exclusion criteria 1) Patients with cancer, severe infectious disease, traumatic disease or hypersensitivity to test drug, and patients who are judged by the principal or other investigator to be ineligible for enrollment in the study.
2) Patients pretreated with DPP-4 inhibitors or GLP-1 analogues.
3) Target PCI lesion is graft stenosis or in-stent restenosis.
4) Patients who had undergone previous PCI for the lesion under investigation.
5) Patients with cardiogenic shock
6) Patients on cyclosporine therapy
7) Patients with liver dysfunction (ALT[GPT] >= 100IU), biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus.
8) Pregnant and possibly pregnant women, lactating women.
9) Patients on maintenance dialysis
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kimura
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email kozookada@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shotaro Kuji
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email kozookada@gmail.com

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 22 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 No longer recruiting
Date of protocol fixation
2013 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2018 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 22 Day
Last modified on
2017 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011822

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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