UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010093 |
|---|---|
| Receipt number | 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 | 2023/03/02 19:03:52 |
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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 | Kazuo |
| Middle name | |
| Last name | Kimura |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
kozookada@gmail.com
Public contact
Name of contact person
| 1st name | Kouzou |
| Middle name | |
| Last name | Okada |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
kozookada@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
Yokohama City University Ethics Committee
Address
3-9 Fukuura,Kanazawa-ku,Yokohama 236-0004 Japan
Tel
045-370-7629
nextjim1@yokohama-cu.ac.jp
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
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
80
Results
Alogliptin treatment, independently of glycemic and lipid status, resulted in significant plaque regression and stabilization in non-culprit coronary lesions in patients with acute coronary syndrome and mild dysglycemia.
Atherosclerosis. 2022 Nov;360:1-7.
Results date posted
| 2023 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 17 | Day |
Baseline Characteristics
STEMI was present in 80% of the patients. DM was present in 42% of the patients (15% for newly diagnosed DM by OGTT, 27% for previous diagnosis of DM) and the remaining 58% of the patients were IGT. HbA1c levels were 6.0 (5.7-6.3) %, indicating that the present study primarily included patients with mild dysglycemia. Both groups showed comparable baseline characteristics, except for slightly lower HbA1c levels in alogliptin than in placebo groups and a tendency toward different distributions of target vessels between the groups.
Participant flow
Eighty patients with ACS and dysglycemia were randomly assigned to receive alogliptin (n=40) or placebo (n=40). Each group excluded 7 patients from the analysis and serial grayscale IVUS and iMAP analyses included 66 patients (33 patients for each group) and 58 patients (30 for alogliptin and 28 for placebo), respectively.
Adverse events
None
Outcome measures
Changes in plaque volume: -0.3 +/- 0.6 vs. -0.04 +/- 0.7 mm3/mm, p = 0.03 for Alogliptin vs. Placebo.
Changes in %necrotic volume (-1.9 +/- 3.8 vs. 0.3 +/- 3.7%, p = 0.03) and %fibrotic volume (2.5 +/- 5.0 vs. -0.3 +/- 5.3%, p = 0.05) for Alogliptin vs. Placebo
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | 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
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011822
