UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000888 |
|---|---|
| Receipt number | R000000969 |
| Scientific Title | Coronary Artery Dysfunction After Stent Implantation and Effect of Aggressive Lipid-lowering Therapy by Statins - Role of Rho-kinase - |
| Date of disclosure of the study information | 2007/11/15 |
| Last modified on | 2011/06/02 01:12:23 |
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Basic information
Public title
Coronary Artery Dysfunction After Stent Implantation and Effect of Aggressive Lipid-lowering Therapy by Statins
- Role of Rho-kinase -
Acronym
Coronary Dysfunction After Stenting and Aggressive Lipid-lowering
- Role of Rho-kinase -
(CONTRACTION study)
Scientific Title
Coronary Artery Dysfunction After Stent Implantation and Effect of Aggressive Lipid-lowering Therapy by Statins
- Role of Rho-kinase -
Scientific Title:Acronym
Coronary Dysfunction After Stenting and Aggressive Lipid-lowering
- Role of Rho-kinase -
(CONTRACTION study)
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of 3-month aggressive lipid-lowering therapy by statin on coronary artery dysfunction after stenting.
Basic objectives2
Others
Basic objectives -Others
To elucidate the role of Rho-kinase in coronary dysfunction after stenting.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Coronary vasospasm after 3-month trial therapy
Key secondary outcomes
1) Cardiovascular events (cardiac death, myocardial infarction, revascularization by PCI or CABG)
2) Severity of angina by Canadian Cardiovascular Society (CCS) classification
3) Biomarkers in peripheral and coronary sinus blood
4) Coronary stenosis and plaque phenotype by angiography or intravascular ultrasound (IVUS)
5) Stent re-endothelialization by angioscopy or optical coherence tomography (OCT)
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
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control therapy:
Slow-release nifedipine (Adalat CR) 20/40mg/day or slow-release diltiazem (Herbesser R) 200mg/day if hypotension is a concern.
Lipid-lowering therapy to achieve LDL-Chol<100mg/dl with statins if needed.
Interventions/Control_2
Experimental therapy:
Slow-release nifedipine (Adalat CR) 20/40mg/day or slow-release diltiazem (Herbesser R) 200mg/day if hypotension is a concern.
Aggressive lipid-lowering therapy to achieve LDL-Chol<70mg/dl with pitavastatin (Livalo) 2-4mg/day.
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
1. Patient of coronary heart disease with prior coronary stenting
2. Patient is planned to undergo follow-up coronary angiography
3. LDL-Chol>70mg/dl
4. Written informed consent for this study
Key exclusion criteria
1. Patient with unstable angina or acute myocardial infarction
2. History of angiographycally-proven vasospastic angina
3. Contraindication for statins or calcium channel blockers
4. Familial hypercholesterolemia, liver cirrhosis or renal failure on chronic dialysis
5. Contraindication for intracoronary acetylcholine during coronary angiography
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sunagawa |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5360
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Matoba |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5360
Homepage URL
matoba@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Sciences
Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Graduate School of Medical Sciences
Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 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
| 2007 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 14 | Day |
Last modified on
| 2011 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000969
