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Recruitment status Completed
Unique ID issued by UMIN UMIN000003486
Receipt No. R000004199
Official scientific title of the study Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy
Date of disclosure of the study information 2010/04/15
Last modified on 2016/08/25

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Basic information
Official scientific title of the study Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy
Title of the study (Brief title) 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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 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
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 0120-203-488
Email empathy@mebix.co.jp

Public contact
Name of contact person Makoto Sawaguchi
Organization EMPATHY Study group
Division name EMPATHY Study group
Address 1-11-44 Akasaka, Minato-ku, Tokyo
TEL 0120-203-488
Homepage URL
Email empathy@mebix.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 04 Month 07 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 05 Month 23 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2010 Year 04 Month 13 Day
Last modified on
2016 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004199


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