UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015147 |
|---|---|
| Receipt number | R000017612 |
| Scientific Title | Nifedipine on coronary vsacular function after drug eluting stent implantation |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2018/03/18 19:52:16 |
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Basic information
Public title
Nifedipine on coronary vsacular function after drug eluting stent implantation
Acronym
NOVEL study (Nifedipine On coronary Vsacular function after drug ELuting stent implantation)
Scientific Title
Nifedipine on coronary vsacular function after drug eluting stent implantation
Scientific Title:Acronym
NOVEL study (Nifedipine On coronary Vsacular function after drug ELuting stent implantation)
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to Investigate whether the treatment with long-acting calcium channel blocker Nifedipine could improve abnormal vasomotor activities after everolimus-eluting stent in the patient with stable angina pectoris.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The vasoconstricting response to Acetylcholine 8-10 months after stent implantation (Quantitative coronary angiolgraphy)
Key secondary outcomes
Blood pressure, heart rate, recurrence of angina pectoris, frequency of angina symptom, biomarker (hs-CRP, adiponectin, PTX3), in-stent restenosis, severe adverse event
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control: Conventional medication (aspirin, clopidogrel, atorvastatin, standard dose of renin-angiontensin system inhibitor)
Interventions/Control_2
Interventions: Adding the long-acting nifedipine (adalat CR) to conventional medication.
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
Stable angina pectoris patient planned to everolimus-eluting stent within 3 months
Key exclusion criteria
Acute coronary syndrome, History of stent implantation in left coronary artery, Vasospastic angina, History of in-stent restenosis, Heart failure with reduced LVEF (<40%), Severe liver dysfunction, Intolerability to dihydropyridin calcium channel blocker, Inappropriate patient considered by an attending doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Graduate School of Medicne
Division name
Department of Cardiovascular Medicine
Zip code
Address
Seiryo-cho 1-1, Aoba-ku, Sendai, Japan
TEL
022-717-7153
shimo@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Takahashi |
Organization
Tohoku University Graduate School of Medicne
Division name
Department of Cardiovascular Medicine
Zip code
Address
Seiryo-cho 1-1, Aoba-ku, Sendai, Japan
TEL
022-717-7153
Homepage URL
jtakahashi@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,Tohoku University Graduate School of Medicne
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
東北大学病院（宮城県）、国立病院機構仙台医療センター（宮城県）、大崎市民病院（宮城県）、みやぎ県南中核病院（宮城県）、仙台オープン病院（宮城県）、いわき市立総合磐城共立病院循環器内科（福島県）、山形県立中央病院（山形県）、平鹿総合病院（秋田県）、岩手県立中央病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017612
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
