UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007900 |
|---|---|
| Receipt number | R000009155 |
| Scientific Title | Effect of Sitagliptin on Plaques and Cardiac Function following ACS |
| Date of disclosure of the study information | 2012/05/07 |
| Last modified on | 2013/11/07 14:57:50 |
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Basic information
Public title
Effect of Sitagliptin on Plaques and Cardiac Function following ACS
Acronym
ESPECIAL-ACS
Scientific Title
Effect of Sitagliptin on Plaques and Cardiac Function following ACS
Scientific Title:Acronym
ESPECIAL-ACS
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome end Type 2 Diabetes Mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ESPECIAL trial will evaluate the effects of DPP4 inhibitor(Sitagliptin) on
coronary plaque regression in patients with acute coronary syndrome.
The study will also assess whether the efficacy of DPP4 inhibitor also
achieve plaque stabilization and improve left ventricular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
percent change in coronary plaque volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diet+ Exercise therapy and Sitagliptin 50-100mg/day
Interventions/Control_2
Diet+ Exercise therapy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with Acute coronary syndrome
2)Patients with coronary plaques (≥500micro m in thickness or 20% or more in % plaque) at ≥5mm from the previously treated area in the same branch of coronary artery.
3)Patients undergoing successful percutaneous coronary intervention (PCI) under IB-IVUS guidance to culprit lesion
4)Patients eating oral diet and drug within 72 hours
5)Patients with diabetes as defined by any of the following criteria: (1) NGSP HbA1c between 6.5% and 7.4% without diabetic drug; (2) NGSP HbA1c less than 7.4% using diabetic drug
6)Patients between 20 years and 80 years old at the time of their consent.
7)Patients giving written consent by their own volition after being provided sufficient explanation for participation in this clinical trial.
Key exclusion criteria
1)diseased bypass graft
2)Patients who have plaque in a non-culprit site on the PCI vessel and might undergo PCI during the treatment period.
3)Patients receiving DPP4 inhibitor drugs and GLP-1 and high dose SU drugs at admission
4)Patients receiving more than 3 anti-diabetic drugs
5)Patients with acute congestive heart failure
6)Patients with ketoacidosis and diabetic coma within 6 months
7)Severe infection, Pre-operative and post-operative state, and severe trauma
8)Pregnant women, women suspected of being pregnant, or lactating women
9)Patients with severe renal disorders or undergoing dialysis
10)Patients with active malignant tumor
11)Patients with any allergy to DPP4 inhibitor
12)Patients who are ineligible in the opinion of the investigator.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Daida |
Organization
Juntendo University
Division name
Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
ktmmy@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsumi Miyauchi |
Organization
Juntendo University
Division name
Cardiovascular Medicine
Zip code
Address
2-1-1 Bunkyo-ku Hongo,Tokyo
TEL
03-3813-3111
Homepage URL
ktmmy@juntendo.ac.jp
Sponsor or person
Institute
ESPECIAL-ACS office
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 05 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 07 | Day |
Last modified on
| 2013 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009155
