UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000571 |
|---|---|
| Receipt number | R000000632 |
| Scientific Title | A randomized control study to see the effect of intensive treatment of hypertension and hyperlipidemia on patients having documented coronary artery disease. |
| Date of disclosure of the study information | 2007/11/29 |
| Last modified on | 2016/03/03 09:37:07 |
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Basic information
Public title
A randomized control study to see the effect of intensive treatment of hypertension and hyperlipidemia on patients having documented coronary artery disease.
Acronym
JCADII(Japanese Coronary Artery Disease Study II)
Scientific Title
A randomized control study to see the effect of intensive treatment of hypertension and hyperlipidemia on patients having documented coronary artery disease.
Scientific Title:Acronym
JCADII(Japanese Coronary Artery Disease Study II)
Region
| Japan |
Condition
Condition
Patients diagnosed as having 75% or higher stenosis according to the AHA classification in at least one branch of the coronary artery with hypertension and hyperlipidemia.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to see the outcome effect of intensive therapy of hyperlipidemia and hypertension on patients having definite coronary artery disease compared with conventional therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoint - all deaths, nonfatal MI/stroke/vascular/peripheral vessel events, unstable angina pectoris, all hospitalization and CABG
Evaluated three years after intervention started.
Key secondary outcomes
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intensive Therapy
Therapeutic Target
BP <120/80mmHg
LDL-C <80mg/dL
Interventions/Control_2
Conventional Therapy
Therapeutic Target
BP <140/90mmHg
LDL-C <100mg/dL
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 20 years-old or older and less than 80 years-old
2) hyperlipidemia
3) hypertension
4) have 75% or more stenosis in at least one branch of the coronary arteries according to the AHA classification diagnosed by either CT or CAG
5) written informed consent to enter the study available
Key exclusion criteria
Patients are excluded from study inclusion if they have
1) allergy to test drugs
2) familial hypercholesterolemia
3) uncontrolled hyperlipidemia (LDL-C >= 180mg/dL)
4) uncontrolled hypertension (systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg)
5) AMI and/or stroke within 3months before intervention
6) secondary hypertension
7) secondary hyperlipidemia
8) severe valvular disease including mitral stenosis or incompetence of the aortic valve
9) severe arrhythmia including ventricular fibrillation or ventricular tachyrhythmia
10) renal failure (serum creatinine >=2.5 mg/dL)
11) liver dysfunction (AST and/or ALT over three times the normal value)
12) pregnancy and/or possibility of pregnancy
or if the attending doctor disqaulifies the patients to be included in the study for whatever reason.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryozo Nagai |
Organization
Tokyo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-6526
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yamazaki |
Organization
Tokyo University Graduate School of Medicine
Division name
Department of Clinical Epidemiology and Systems
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9844
Homepage URL
heart-kenkyukai@umin.ac.jp
Sponsor or person
Institute
J-CADII study committee
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2007 | Year | 11 | Month | 29 | 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
| 2006 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 01 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000632
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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