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Recruitment status Completed
Unique ID issued by UMIN UMIN000015147
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email jtakahashi@cardio.med.tohoku.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine,Tohoku University Graduate School of Medicne
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017612


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