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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001105
Receipt No. 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

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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
Email

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
Email oikawa@cvi.or.jp

Sponsor
Institute The Cardiovascular Institute
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001337

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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