Carvedilol Post-intervention Long-term Administration in Large-scale Trial (CAPITAL-RCT)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Carvedilol
No Carvedilol
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Adrenergic beta-Antagonists, Percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria:
- Patients with STEMI after primary PCI
- Patients with left ventricular ejection fraction more than or equal to 40%
Exclusion Criteria:
- Patients with left ventricular ejection fraction less than 40%
- Patients with contraindication for beta-blocker
- Patients with implantable cardioverter defibrillators
- Patients with end-stage malignancy
Sites / Locations
- Division of Cardiology, Kyoto University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Beta-blocker
Non Beta-blocker
Arm Description
Use of Carvedilol with any dose
No use of Carvedilol
Outcomes
Primary Outcome Measures
All cause mortality
Death from any reason
Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Secondary Outcome Measures
Cardiac death
Sudden cardiac death
Cardiovascular death
Myocardial infarction
Acute coronary syndrome
Sustained ventricular tachycardia or ventricular fibrillation
Heart failure hospitalization
Stent thrombosis
Stent thrombosis defined by Academic Research Consortium
Target-vessel revascularization
Clinically-driven target-lesion revascularization
Any coronary revascularization
Any clinically-driven coronary revascularization
Coronary artery bypass grafting
Stroke
Any ischemic and hemorrhagic strokes excluding transient ischemic attacks
Worsening of angina due to coronary spasm
Bleeding complications
Bleeding complications defined by GUSTO and TIMI definitions
Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization
Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Composite of cardiovascular death, myocardial infarction, stroke
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01155635
Brief Title
Carvedilol Post-intervention Long-term Administration in Large-scale Trial
Acronym
CAPITAL-RCT
Official Title
Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.
Detailed Description
Beta-blocker therapy is recommended after ST-segment elevation acute myocardial infarction (STEMI) in the current guidelines although its efficacy in those patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. 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. The design of this study is multicenter, open-label, randomized controlled trial enrolling 1300 patients without any exclusion criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Adrenergic beta-Antagonists, Percutaneous coronary intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
801 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beta-blocker
Arm Type
Active Comparator
Arm Description
Use of Carvedilol with any dose
Arm Title
Non Beta-blocker
Arm Type
Active Comparator
Arm Description
No use of Carvedilol
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
Use of Carvedilol with any dose
Intervention Type
Drug
Intervention Name(s)
No Carvedilol
Intervention Description
No use of Carvedilol
Primary Outcome Measure Information:
Title
All cause mortality
Description
Death from any reason
Time Frame
6-year
Title
Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Time Frame
6-year
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
6-year
Title
Sudden cardiac death
Time Frame
6-year
Title
Cardiovascular death
Time Frame
6-year
Title
Myocardial infarction
Time Frame
6-year
Title
Acute coronary syndrome
Time Frame
6-year
Title
Sustained ventricular tachycardia or ventricular fibrillation
Time Frame
6-year
Title
Heart failure hospitalization
Time Frame
6-year
Title
Stent thrombosis
Description
Stent thrombosis defined by Academic Research Consortium
Time Frame
6-year
Title
Target-vessel revascularization
Time Frame
6-year
Title
Clinically-driven target-lesion revascularization
Time Frame
6-year
Title
Any coronary revascularization
Time Frame
6-year
Title
Any clinically-driven coronary revascularization
Time Frame
6-year
Title
Coronary artery bypass grafting
Time Frame
6-year
Title
Stroke
Description
Any ischemic and hemorrhagic strokes excluding transient ischemic attacks
Time Frame
6-year
Title
Worsening of angina due to coronary spasm
Time Frame
6-year
Title
Bleeding complications
Description
Bleeding complications defined by GUSTO and TIMI definitions
Time Frame
6-year
Title
Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization
Time Frame
6-year
Title
Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
Time Frame
6-year
Title
Composite of cardiovascular death, myocardial infarction, stroke
Time Frame
6-year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with STEMI after primary PCI
Patients with left ventricular ejection fraction more than or equal to 40%
Exclusion Criteria:
Patients with left ventricular ejection fraction less than 40%
Patients with contraindication for beta-blocker
Patients with implantable cardioverter defibrillators
Patients with end-stage malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30153268
Citation
Watanabe H, Ozasa N, Morimoto T, Shiomi H, Bingyuan B, Suwa S, Nakagawa Y, Izumi C, Kadota K, Ikeguchi S, Hibi K, Furukawa Y, Kaji S, Suzuki T, Akao M, Inada T, Hayashi Y, Nanasato M, Okutsu M, Kametani R, Sone T, Sugimura Y, Kawai K, Abe M, Kaneko H, Nakamura S, Kimura T; CAPITAL-RCT investigators. Long-term use of carvedilol in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. PLoS One. 2018 Aug 28;13(8):e0199347. doi: 10.1371/journal.pone.0199347. eCollection 2018.
Results Reference
derived
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Carvedilol Post-intervention Long-term Administration in Large-scale Trial
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