UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001105 |
|---|---|
| Receipt number | R000001337 |
| Scientific Title | Comparison of therapeutic effects of long-acting calcium channel blockers on coronary vasospasm.; Open label randomized trial (ATTACK VSA TRIAL) |
| Date of disclosure of the study information | 2008/04/01 |
| Last modified on | 2011/04/04 10:16:12 |
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Basic information
Public title
Comparison of therapeutic effects of long-acting calcium channel blockers on coronary vasospasm.; Open label randomized trial (ATTACK VSA TRIAL)
Acronym
Comparison of therapeutic effects of long-acting calcium channel blockers on coronary vasospasm.
Scientific Title
Comparison of therapeutic effects of long-acting calcium channel blockers on coronary vasospasm.; Open label randomized trial (ATTACK VSA TRIAL)
Scientific Title:Acronym
Comparison of therapeutic effects of long-acting calcium channel blockers on coronary vasospasm.
Region
| Japan |
Condition
Condition
Vasospastic Angina Pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the therapeutic effects of nifedipin retard with other long-acting calcium channel blockers on vasospastic angina pectoris patients by prospective study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. comparison the numbers of episode(times/week) or the consumption of the short-acting nitrates (tablets/week) between before and after of treatment
2. Efficacy rate: Evaluate 2 treatment groups each by following five degree. 1) well improved, 2) improved, 3) less improved, 4) no change, 5) deterioration, 6) impossible to judge, after consideration following subjects, such as number and severity of episodes, consumption of short-acting nitrates, and total impression, together in each group.
3. Improvement of 24 hours electrocardiogram: (When the measurement was carried out in an institution) Evaluate 2 treatment groups each by following 3 degree. 1) improved, 2) no change, 3) deterioration, 4) impossible to judge, after consideration following subjects, such as number of ST rising, maximum degree of ST rising, or continuance time of ST rising, together in each group.
4. entire improvement: after consideration of #2 and #3, evaluate both treatment groups by following five degrees, and compare both groups
1) well improved, 2) improved, 3) less improved, 4) no change, 5) deterioration, 6) impossible to judge
5. About above end-points of #1 to #4, compare both treatment groups according to a patient background
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Benidipine administration group: administrate a Benidipine 4mg tablet twice a day after breakfast and supper. The dose can be changed according to the symptom
Interventions/Control_2
Nifedipine administration group: administrate a nifedipine 40 mg tablet after supper. The dose can be changed according to the symptom but maximum dose should be 60mg/once/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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with coronary vasospasm, and categorized at least one of following 2 conditions
1)patients who is positive of ischemic ST-segment change when chest pain appears at rest, or patients who is negative with exercise test.
2)Patients with coronary vasospasm and show ischemic ST-segment change on electrocardiogram by selective acetylcholine or ergonovine -loading test
Key exclusion criteria
1. patients who have organic coronary narrowing only but don't have coronary vasospasm
2. patient with acute myocardial infarction (within one month)
3. diabetes mellitus patients with poorly-controlled glycemia
4. severe hypertensive patients(>=180/>=110mmHg)
5. patients who is not able to administrate dihydropyridine calcium channel blockers
6. Patients who is not allowed to enroll the trial by doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Oikawa |
Organization
The Cardiovascular Institute
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-10 Roppongi Minato-ku Tokyo, 106-0032, Japan
TEL
03-3408-2151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Oikawa |
Organization
The Cardiovascular Institute
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-10 Roppongi Minato-ku Tokyo, 106-0032, Japan
TEL
03-3408-2151
Homepage URL
oikawa@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toranomon Hospital
Toho University Ohashi Medical Center
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
| 2008 | Year | 04 | Month | 01 | 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
| 2006 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 01 | Day |
Last modified on
| 2011 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001337
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