UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003486 |
|---|---|
| Receipt number | R000004199 |
| Scientific Title | Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy |
| Date of disclosure of the study information | 2010/04/15 |
| Last modified on | 2019/07/23 10:25:34 |
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Basic information
Public title
Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy
Acronym
Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy (EMPATHY)
Scientific Title
Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy
Scientific Title:Acronym
Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy (EMPATHY)
Region
| Japan |
Condition
Condition
Hypercholesterolemia complicated with diabetic retinopathy
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of standard/intensive lipid-control therapies in patients with hypercholesterolemia complicated with diabetic retinopathy without history of coronary arterial diseases treated with statin monotherapy, using onset of cardiovascular diseases/death as an endpoint. In addition, to investigate the safety of standard/intensive lipid-control therapies using incidence rates of adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Lipid-control will be conducted with statin monotherapy in patients with hypercholesterolemia complicated with diabetic retinopathy. Using time until the onset of cardiovascular diseases/death as an endpoint, it will be determined whether the inhibitory effect of the intensive lipid-control therapy on the onset of cardiovascular diseases is superior to that of the standard one.
Cardiovascular diseases include the following:
- cardiac event: MI, unstable angina pectoris requiring unscheduled hospitalization, coronary revascularization (PTCA, CABG)
- cerebral event: cerebral infarction, cerebrovascular revascularization
- Renal event: initiation of permanent dialysis, 2-fold or more increase in serum creatinine (and > 1.5 mg/dL)
- vascular event: aortic/peripheral arterial diseases (onset of aortic dissection, mesenteric artery thrombosis, or arteriosclerosis obliterans-related severe ischemia (ulcer) of lower limbs, or finger/leg amputation)
Key secondary outcomes
1) Efficacy will be assessed using the following evaluation parameters:
- total deaths
- onset of individual cardiac, cerebral, renal, vascular events
- onset of stroke (cerebral infarction, cerebral hemorrhage, subarachnoid haemorrhage)
- changes (measured value, rate) in CKD-related parameters (eGFR, urinary albumin, urinary protein)
2) Safety of the therapies will be evaluated using incidence rates of adverse events as an evaluation parameter.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intensive lipid-control therapy group: LDL-C <70 mg/dL
Observation period: 2-5.5 years
Interventions/Control_2
Standard lipid-control therapy group: LDL-C 100 <= LDL-C < 120 mg/dL
Observation period: 2-5.5 years
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy all of the following criteria will be included.
At interim registration:
1) patients who give written consent to participation in the study at their own will
2) at the age of 30 years or above (at consent acquisition)
3) male or female (except females with possibility of pregnancy)
4) Inpatient / outpatient: outpatient
5) patients with hypercholesterolemia whose LDL-C is 120 mg/dL or more for treatment-naive patients or 100 mg/dL or more for patients with experience of monotherapy using statins (in case of patients with atorvastatin, pitavastatin, or rosuvastatin, they must be treated with up to 10mg/day, 2mg/day, 2.5mg/day, respectively) or lipid-lowering drugs
6) patients with type II diabetes
7) patients with no history of coronary arterial diseases (MI, angina pectoris, coronary revascularization).
At official registration:
1) patients with diabetic retinopathy
Key exclusion criteria
Patients to whom any of the following criteria apply will be excluded from the study:
at interim registration:
1) patients with history of hypersensitivity to statins
2) patients with history of drug-induced muscle disorder
3) patients with history of coronary arterial diseases (MI, angina pectoris, coronary revascularization)
4) patients with history of stroke (including revascularization)
5) patients complicated with symptomatic PAD (Fontaine class II or above)
6) hypertensive patients with diastolic BP of 120 mmHg or more or systolic BP of 200 mmHg or more, or patients with hypertensive emergency
7) patients with NYHA functional class IIM or more
8) patients with cardiac valvulopathy who have serious hemodynamic abnormality
9) patients under treatment with at least 2 different lipid-lowering drugs
10) patients with familial hypercholesterolemia
11) patients with serious complications e.g. malignant tumors or patients with limited life expectancy (however, patients who are decided free of relapse without treatment of malignant tumors over five years before obtaining their informed consent are able to be enrolled)
12) patients with renal transplant or patients under dialysis
13) patients who are pregnant or who are at risk of pregnancy, or those who desire to become pregnant during their participation in the study
14) other patients deemed unsuitable by the principal investigator or investigator.
At official registration: The study will be discontinued in patients who have undergone prespecified examinations during the observation period and satisfy any of the following criteria:
1) patients with apparent ischemia in ECG at rest
2) patients with AST of 100 IU/L or above or ALT of 100 IU/L or above
3) patients with serum creatinine of 2.0 mg/dL or more or eGFR of 30 mL/min/1.73 m2 or less
4) patients with nephrotic syndrome
5) patients with serum triglyceride of 1000 mg/dL or more
6) other patients deemed unsuitable by the principal investigator or investigator.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Issei Komuro, Hiroshi Ito |
Organization
Tokyo University Graduate School of
Medicine
Keio University School of Medicine
Division name
Cardiovascular Medicine, Medicine I, Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0120-203-488
empathy@mebix.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Sawaguchi |
Organization
EMPATHY Study group
Division name
EMPATHY Study group
Zip code
Address
1-11-44 Akasaka, Minato-ku, Tokyo
TEL
0120-203-488
Homepage URL
empathy@mebix.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2010 | Year | 04 | Month | 15 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 13 | Day |
Last modified on
| 2019 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004199
