Carvedilol Post-intervention Long-term Administration in Large-scale Trial (CAPITAL-RCT)

This study is currently recruiting participants.
Verified December 2012 by Kyoto University, Graduate School of Medicine
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01155635
First received: July 1, 2010
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Carvedilol
Drug: No Carvedilol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 6-year ] [ Designated as safety issue: No ]
    Death from any reason

  • Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization [ Time Frame: 6-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Sudden cardiac death [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Acute coronary syndrome [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Sustained ventricular tachycardia or ventricular fibrillation [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Heart failure hospitalization [ Time Frame: 6-year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 6-year ] [ Designated as safety issue: No ]
    Stent thrombosis defined by Academic Research Consortium

  • Target-vessel revascularization [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Clinically-driven target-lesion revascularization [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Any coronary revascularization [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Any clinically-driven coronary revascularization [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Coronary artery bypass grafting [ Time Frame: 6-year ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 6-year ] [ Designated as safety issue: Yes ]
    Any ischemic and hemorrhagic strokes excluding transient ischemic attacks

  • Worsening of angina due to coronary spasm [ Time Frame: 6-year ] [ Designated as safety issue: Yes ]
  • Bleeding complications [ Time Frame: 6-year ] [ Designated as safety issue: No ]
    Bleeding complications defined by GUSTO and TIMI definitions

  • Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization [ Time Frame: 6-year ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization [ Time Frame: 6-year ] [ Designated as safety issue: Yes ]
  • Composite of cardiovascular death, myocardial infarction, stroke [ Time Frame: 6-year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1300
Study Start Date: July 2010
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Beta-blocker
Use of Carvedilol with any dose
Drug: Carvedilol
Use of Carvedilol with any dose
Active Comparator: Non Beta-blocker
No use of Carvedilol
Drug: No Carvedilol
No use of Carvedilol

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155635

Contacts
Contact: Takeshi Kimura, MD +81-75-751-4254 taketaka@kuhp.kyoto-u.ac.jp
Contact: Takeshi Morimoto, MD +81-75-751-4890 office@kuhp.kyoto-u.ac.jp

Locations
Japan
Division of Cardiology, Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Takeshi Kimura, MD    +81-75-751-4254    taketaka@kuhp.kyoto-u.ac.jp   
Contact: Neiko Ozasa, MD    +81-75-751-4255    nei126@kuhp.kyoto-u.ac.jp   
Principal Investigator: Takeshi Kimura, MD         
Sponsors and Collaborators
Takeshi Morimoto
Investigators
Principal Investigator: Takeshi Kimura, MD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01155635     History of Changes
Other Study ID Numbers: C-417
Study First Received: July 1, 2010
Last Updated: December 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University, Graduate School of Medicine:
Myocardial infarction
Adrenergic beta-Antagonists
Percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Carvedilol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on April 16, 2014