UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010091 |
|---|---|
| Receipt number | 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 | 2022/09/24 14:54:28 |
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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 | Hisao |
| Middle name | |
| Last name | Ogawa |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5175
ogawah@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Kaikita |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5175
Homepage URL
kaikitak@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
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
Institutional Review Board
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
Tel
096-373-5657
iyg-igaku@jimu.kumamoto-u.ac.jp
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
97
Results
There were no significant differences in the baseline clinical characteristics except younger age in nifedipine compared with benidipine groups.
In age-adjusted model, the difference of dilator response to ISDN between initial and follow-up ACh tests was almost identical between 2 groups. However, the difference of constrictor response to ACh was significantly improved in the nifedipine rather than benidipine groups.
Results date posted
| 2022 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences in baseline clinical characteristics except younger age in nifedipine compared with benidipine groups.
Participant flow
ACROSS-AMI study is an open label, multicenter study of 97 consecutive AMI patients who underwent percutaneous coronary intervention (PCI) and had no residual stenosis in major left coronary artery (LCA). The 84 AMI patients who were positive for initial acetylcholine (ACh) provocation test in LCA (LACh) 1-2 weeks post-MI were randomized into 2 groups treated with nifedipine (N=43) and benidipine (N=41). After exclusion of 14 patients, data of 70 AMI patients [nifedipine (N=35) and benidipine (N=35)] were eligible for the present analysis.
Adverse events
In studies 1 and 2, the nifedipine group (studies 1 + 2: 48 subjects) had hypotension (1 patient, 2.1%), headache (1 patient, 2.1%), edema (1 patient, 2.1%), A dull headache (1 patient, 2.1%) was observed, and an adverse event of skin eruption (1 patient, 2.3%) was observed in the benidipine group (Study 1: 43 patient).
Outcome measures
The primary end point is the changes in coronary vasodilator response to ISDN and vasoconstrictor response to ACh by using QCA between ACh provocation test 2 weeks and 6-9 months after AMI. Coronary vasodilator response to ISDN and Coronary vasoconstrictor response to ACh were calculated by the following formula.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
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
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011818
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