UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003256 |
|---|---|
| Receipt number | 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 | 2021/02/19 18:32:52 |
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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 | Takeshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL
075-751-4255
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL
075-751-4255
Homepage URL
nei126@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department
Personal name
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
the ethical committee in Kyoto University Hospital.
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT 01155635
Org. issuing International ID_1
ClinicalTrials.gov.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Juntendo University Shizuoka Hospital, Tenri Hospital, Kurashiki Central Hospital, Shiga Medical Center for Adults, Kyoto University Hospital, Yokohama City University Medical Center, Kobe City Medical Center General Hospital, Toyohashi Heart Center, National Hospital Organization Kyoto Medical Center, Osaka Red Cross Hospital, Tsuchiya General Hospital, Nagoya Daini Red Cross Hospital, Nozaki Tokushukai Hospital, Nagoya Tokushukai General Hospital, Ogaki Municipal Hospital, Kawakita General Hospital, Chikamori Hospital, Yotsuba Circulation Clinic, Hoshi General Hospital, New Tokyo Hospital, Shimada Municipal Hospital, Hiroshima City Hiroshima Citizens Hospital, Showa University Hospital, Gunma Cardiovascular Center, Kindai University Nara Hospital, Yamaguchi University Hospital, Toyama Prefectural Central Hospital, Hitachi General Hospital, National Cerebral and Cardiovascular Center, Saitama Cardiovascular and Respiratory Center, Yamagata Prefectural Central Hospital, Shizuoka City Shizuoka Hospital, Tokai University Hospital, Nagoya City East Medical Center, Kokura Memorial Hospital, Higashisumiyoshi Morimoto Hospital, Nara Prefectural Seiwa Medical Center, Tsukazaki Hospital, Kansai Electric Power Hospital, Mitsui Memorial Hospital, Fujioka General Hospital, Nihon University Itabashi Hospital, Iida Municipal Hospital, Otsu Red Cross Hospital, Fukuoka Wajiro Hospital, Fukuoka Tokushukai Hospital, Tachikawa Medical Center Tachikawa General Hospital, Miyazaki Medical Association Hospital, Saiseikai Kumamoto Hospital, Rakuwakai Otowa Hospital, Sakakibara Memorial Hospital, Wakayama Medical University Hospital, Hirosaki University Hospital, Maizuru Kyosai Hospital, Shiga University Of Medical Science Hospital, Saitama Medical Center Jichi Medical University, Japanese Red Cross Wakayama Medical Center, Toho University Ohashi Hospital, Tsukuba Medical Center Hospital, Kyoto Chubu Medical Center, Saga-ken Medical Center Koseikan, Hyogo Prefectural Amagasaki General Medical Center, Kindai University Hospital, Seirei Mikatahara General Hospital, Teikyo University Hospital, Kanazawa Cardiovascular Hospital, Kobe University Hospital
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112626/#pone.0199347.s003
Publication of results
Published
Result
URL related to results and publications
Published online 2018 Aug 28. doi: 10.1371/journal.pone.0199347
Number of participants that the trial has enrolled
801
Results
During median follow-up of 3.9 years with 96.4% follow-up, the cumulative 3-year incidences of both the primary endpoint and any coronary revascularization were not significantly different between the carvedilol and no beta-blocker groups :6.8% and 7.9%, P=0.20, and 20.3% and 17.7%, P=0.65, respectively.
Results date posted
| 2021 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 08 | Month | 28 | Day |
Baseline Characteristics
Patients were eligible for the trial if they underwent successful primary PCI within 24hours after the onset of STEMI and had preserved left ventricular ejection fraction LVEF>=40% as assessed by echocardiography.
Participant flow
After screening for eligibility and obtaining written informed consent, the enrolled patients were randomly assigned in a 1-to-1 ratio to the carvedilol group or to the no beta-blocker group within 7 days after primary PCI. Randomization was performed centrally through the electronic data capture system with a stochastic minimization algorithm to balance treatment assignment. Carvedilol was selected as the specific beta-blocker in the present study, because this agent was tested in the most recent trial evaluating the role of long-term oral beta-blocker therapy in STEMI patients (CAPRICORN trial)[2], and was the most widely used beta-blocker for STEMI patients in Japan[9]. In the carvedilol group, carvedilol was to be started from low doses and up-titrated to the target dose of 20mg daily, though the initial dose and titration of carvedilol was at the discretion of the attending physicians. The administration of other standard medications for STEMI patients such as aspirin, thienopyridines, statins, and inhibitors of the renin angiotensin system were also left to their decision.
Adverse events
No adverse event due to study drug was reported.
Outcome measures
The primary endpoint was a composite of all-cause death, myocardial infarction (MI), hospitalization for acute coronary syndrome (ACS), and hospitalization for HF.
The secondary endpoints included the individual components of the primary endpoint as well as cardiac death, non-cardiac death, stroke, vasospastic angina, major bleeding, definite stent thrombosis (ST), target-lesion revascularization (TLR), and any coronary revascularization. Also, we evaluated 3 composite endpoints including cardiac death/MI/ACS/HF, cardiovascular death/MI/stroke, and death/MI/stroke/ACS/HF/any coronary revascularization.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 12 | Day |
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
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003891
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