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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010091
Receipt No. R000011818
Scientific Title A prospective randomized clinical trial, the effect of long acting CCBs in post-acute myocardial infarction patients
Date of disclosure of the study information 2013/02/21
Last modified on 2013/11/12

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Basic information
Public title A prospective randomized clinical trial, the effect of long acting CCBs in post-acute myocardial infarction patients
Acronym ACROSS-AMI (ACh-induced Coronary Spasm Study - Nifedipine and Benidipine After Acute Myocardial Infarction)
Scientific Title A prospective randomized clinical trial, the effect of long acting CCBs in post-acute myocardial infarction patients
Scientific Title:Acronym ACROSS-AMI (ACh-induced Coronary Spasm Study - Nifedipine and Benidipine After Acute Myocardial Infarction)
Region
Japan

Condition
Condition ST-segment elevation myocardial infarction(STEMI) or non-ST elevation myocardial infarction(NSTEMI)
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the inhibitory effect of CCBs (Nifedipine / Adalat CR or Benidipine / Coniel) on coronary spasm and coronary endothelial dysfunction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes A rate of changes in ACh-provoked coronary constrictive response and degree of coronary vascular tone at the follow up CAG, 6-12 months after onset.
Key secondary outcomes (1)Incidence of coronary spasm at the 2nd ACh-provocation test
(2)Change in biomarkers
(3)Cardiovascular events(cardiovascular death, non-fatal MI, UAP, rehospitalization for heart failure, re-PCI etc)
(4)Adverse effects
(5)Coronary lesion finding by OCT(if possible)

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 considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ACh-provocation test positive / Nifedipine arm
Interventions/Control_2 ACh-provocation test positive / Benidipine arm
Interventions/Control_3 ACh-provocation test negative / Control arm
Interventions/Control_4 ACh-provocation test negative / Nifedipine arm
Interventions/Control_5 ACh-provocation test negative / Benidipine arm
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients that ACh-provocation test was performed within 2 weeks after hospitalization and no PCI-needed residual lesions were observed at discharge
2) Age: 20-85 years old
3) Patients that written informed consents were obtained
Key exclusion criteria Patients with
1) Unstable angina (UAP)
2) Triple vessel disease
3) Left ventricular ejection fraction <40%
4) Chronic atrial fibrillation
5) Severe hepatic dysfunction
6) Low tolerability of DHP-CCB
7) A history of DES implantation
8) Patients who were recognized by the chief physician to be inappropriate for study participation
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto
TEL 096-373-5175
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Kaikita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto
TEL 096-373-5175
Homepage URL
Email kaikitak@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

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 熊本大学医学部附属病院(熊本県)
済生会熊本病院(熊本県)
横浜市立大学市民総合医療センター(神奈川県)
愛媛県立新居浜病院(愛媛県)
国立循環器病研究センター(大阪府)
日本医科大学千葉北総病院(千葉県)
昭和大学藤が丘病院(神奈川県)
広島鉄道病院(広島県)
東京女子医大八千代医療センター(千葉県)
心臓血管研究所付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 21 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 Enrolling by invitation
Date of protocol fixation
2013 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 21 Day
Last modified on
2013 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011818

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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