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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000571
Receipt No. 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

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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
Email

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
Email heart-kenkyukai@umin.ac.jp

Sponsor
Institute J-CADII study committee
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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