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

This study has been completed.
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: January 5, 2016
Last verified: December 2015
  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 ]

Enrollment: 801
Study Start Date: July 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155635

Locations
Japan
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 606-8507
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

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: January 5, 2016
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
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on July 26, 2016