UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003548 |
|---|---|
| Receipt number | R000004304 |
| Scientific Title | Intensive lipid and blood pressure lowering and cardiovascular outcome: Randomised controlled trial on patients with coronary artery disease and type 2 diabetes |
| Date of disclosure of the study information | 2010/04/28 |
| Last modified on | 2010/04/27 11:45:01 |
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Basic information
Public title
Intensive lipid and blood pressure lowering and cardiovascular outcome: Randomised controlled trial on patients with coronary artery disease and type 2 diabetes
Acronym
Randomised controlled trial of intensive lipid and blood pressure lowering in diabetic CAD patients
Scientific Title
Intensive lipid and blood pressure lowering and cardiovascular outcome: Randomised controlled trial on patients with coronary artery disease and type 2 diabetes
Scientific Title:Acronym
Randomised controlled trial of intensive lipid and blood pressure lowering in diabetic CAD patients
Region
| Japan |
Condition
Condition
Coronary artery disease and type 2 diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effectiveness and safety of intensive lipid (target LDL choleterol 70-85 mg/dl) and blood pressure (target systolic blood pressure <120mmHg) in diabetic patients with coronary artery disease and history of myocardial infarction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Composite endpoint: total mortality, myocardial infarction, stroke, unstable angina
Key secondary outcomes
Total and cardiovascular mortality, myocardial infarction, stroke, unstable angina,new onset of heart failure, hospital administration due to heart failure,end stage renal disease
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
Intensive therapy that targeted systolic blood pressures of less than 120 mm Hg and LDL cholesterol of 70-85 mg/dl. Any treatment strategies that are currently available in clinical practice can be used to lower LDL cholesterol and blood pressure.
Interventions/Control_2
Standard therapy that targeted systolic blood pressures of less than 130 mm Hg and LDL cholesterol of less than 100 mg/dl according to current guidelines.
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
Type 2 diabetic patients with coronary artery disease and history of myocardial infarction whose systolic blood pressure is >130 mmHg (more than two occasions) and LDL cholesterol is >100mg/dl.
Key exclusion criteria
(1) With active malignant tumor
(2) On hemodialysis due to chronic renal failure
(3) Contraindication of statin therapy
(4) Acute myocardial infarction, stroke and unstable angina (as acute coronary syndrome)within 3 months
(5) pregnancy and breast feeding
(6)Any factors likely to limit adherence to interventions
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Ueda |
Organization
University of the Ryukyus Graduate School of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
207, Uehara, Nshihara-cho, Okinawa
TEL
0988951195
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Ueda |
Organization
University of the Ryukyus Graduate School of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
207, Uehara, Nshihara-cho, Okinawa
TEL
0988951195
Homepage URL
suedano9@dream.com
Sponsor or person
Institute
Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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
琉球大学医学部附属病院（沖縄県）豊見城中央病院（沖縄県）与那原中央病院（沖縄県）、沖縄赤十字病院（沖縄県），沖縄協同病院（沖縄県）、ちばなクリニック（沖縄県）、佐賀大学病院（佐賀県）徳島大学医学部附属病院（徳島県）、広島大学病院（広島県）、島根大学病院（島根県）済生会二日市病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 27 | Day |
Last modified on
| 2010 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004304
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