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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003256
Receipt No. R000003891
Scientific Title Carvedilol Post-Intervention long-Term Administration in Large-scale Randomized Controlled Trial
Date of disclosure of the study information 2010/03/31
Last modified on 2017/02/17

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Basic information
Public title Carvedilol Post-Intervention long-Term Administration in Large-scale
Randomized Controlled Trial
Acronym CAPITAL-RCT
Scientific Title Carvedilol Post-Intervention long-Term Administration in Large-scale
Randomized Controlled Trial
Scientific Title:Acronym CAPITAL-RCT
Region
Japan

Condition
Condition Acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate whether beta-blocker, carvedilol improves 6-year clinical outcomes in patients with STEMI and preserved left ventricular ejection fraction after primary PCI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)All cause mortality
2)Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Key secondary outcomes 1) Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any revascularization
2) Composite of cardiac death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any revascularization
3) Composite of cardiac death, myocardial infarction, stroke
4) Cardiac death
5) Sudden cardiac death
6) Cardiovascular death
7) Myocardial infarction
8) Acute coronary syndrome
9) Sustained ventricular tachycardia or ventricular fibrillation
10) Heart failure hospitalization
11) Stent thrombosis(ARC Definite)
12) Target vessel revascularization
13) Clinically-driven target-lesion revascularization
14) Any revascularization
15) Any clinically-driven coronary revascularization
16) Coronary artery bypass grafting
17) Stroke
18) Worsening of angina due to coronary spasm
19) Bleeding complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carvedilol
Interventions/Control_2 none Carvedilol
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with STEMI after primary PCI
2)Patients with left ventricular ejection fraction more than or equal to 40%
Key exclusion criteria 1)Patients with contraindication for beta-blocker
2)Patients with left ventricular ejection fraction less than 40%
3)Patients with implantable cardioverter defibrillators
4)Patients with end-stage malignancy
Target sample size 1300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takesi Kimura
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-751-4255
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Neiko Ozasa
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-751-4255
Homepage URL
Email nei126@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department

Funding Source
Organization Department of Cardiovascular medicine, Kyoto University Graduate School of Medicine, Research Scholarships
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 31 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
2010 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 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
2010 Year 02 Month 25 Day
Last modified on
2017 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003891

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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