search
Back to results

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
Takeshi Morimoto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 1, 2010
Last Updated
June 25, 2017
Sponsor
Takeshi Morimoto
search

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

Learn more about this trial

Carvedilol Post-intervention Long-term Administration in Large-scale Trial

We'll reach out to this number within 24 hrs