UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000930 |
|---|---|
| Receipt number | R000001052 |
| Scientific Title | Secondary Protective effect of ca-antagonist for ischemic heart attack randominzed parallel comparison with beta-blocker trial |
| Date of disclosure of the study information | 2007/12/04 |
| Last modified on | 2009/06/12 13:03:57 |
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Basic information
Public title
Secondary Protective effect of ca-antagonist for ischemic heart attack
randominzed parallel comparison with beta-blocker trial
Acronym
SPECIAL
Scientific Title
Secondary Protective effect of ca-antagonist for ischemic heart attack
randominzed parallel comparison with beta-blocker trial
Scientific Title:Acronym
SPECIAL
Region
| Japan |
Condition
Condition
Ischemic heart disease (post-myocardila infarction angina, angina pectoris)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To clarify the differences of protective effects on cardiovascular events between atenolol and benidipine.
2.To clarify protective effects of benidipine in the patients with vasospastic angina.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cardiovascular evetns including myocardial infarction, angina, silent myocardial ischemia, taget lesion revascularization, cerebral infarction, intracerebral hemorrhage
Key secondary outcomes
1. all death
2. hospitalization due to heart failure etc
3. renal failure (hemodialysis)
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 adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
atenolol-treated group
dose: 50 mg QD
maximum dose: 100mg
Permission to change the dose according to age or symptoms.
Interventions/Control_2
benidipine-treated group
dose: 4mg BID
Permission to change the dose according to age or symptoms.
Interventions/Control_3
vasospastic angina patient group
benidipine dose: 4mg BID
Permission to change the dose according to age or symptoms.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. post-myocardial angina
healed myocardial infarction or
>1 month after acute
myocardial infarction under stable
conditions
2. angina pectoris
>=1mm ST deviation on chest pain was observed and coronary angiography within 6 months revealed 75%<= stenosis
Vasospasm
Acetylcholineor ergonobin induced vasospasm, catheter-induced vasospasm, or 1mm<= ST elevation on chest pain
Key exclusion criteria
1) previous history of hypersensitivity or intolerance of atenolol or benidipine
2) cardiogenic shock
3)diabetic ketoacidosis, metabolic acidosis
4)severe or symptomatic bradycardia, atrioventricular block (II, III degree), sinoatrial block, sick sinus syndrome
5)critical arrhythmia
6)right ventricular failure with pulmonary hypertension
7)congestive heart failure
8)hypotension
9)severe peripheral arterial disease (gangrene etc)
10)untreated pheochromocytoma
11)any women who is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
12)severe hepatic failure (total bilirubin >2.0mg/dL)
13)severe renal failure (serum creatinin >3.0mg/dL)
14)infection, paralytic or obstractive ileus
15)ongoing or planning treatment with anti-cancer drugs
16)other serious illness or significant abnormalities that the investigator judges inappropriate for the study
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruo Takano |
Organization
Nippon Medical School
Division name
Department of Internal Medicine, division of cardiology
Zip code
Address
1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL
03-3822-2131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Mizuno |
Organization
Nippon Medical School
Division name
Department of Internal Medicine, division of cardiology
Zip code
Address
1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School, Department of Internal Medicine, division of cardiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nippon Medical School, Chiba Hokusoh hospital, Musashi Kosugi hospital, Tama Nagayama hospital
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
| 2007 | Year | 12 | Month | 04 | 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
Completed
Date of protocol fixation
| 2001 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 04 | Day |
Last modified on
| 2009 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001052
