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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01155635
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Carvedilol Drug: No Carvedilol Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 801 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
Study Start Date : July 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Carvedilol

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 6-year ]
    Death from any reason

  2. Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization [ Time Frame: 6-year ]

Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: 6-year ]
  2. Sudden cardiac death [ Time Frame: 6-year ]
  3. Cardiovascular death [ Time Frame: 6-year ]
  4. Myocardial infarction [ Time Frame: 6-year ]
  5. Acute coronary syndrome [ Time Frame: 6-year ]
  6. Sustained ventricular tachycardia or ventricular fibrillation [ Time Frame: 6-year ]
  7. Heart failure hospitalization [ Time Frame: 6-year ]
  8. Stent thrombosis [ Time Frame: 6-year ]
    Stent thrombosis defined by Academic Research Consortium

  9. Target-vessel revascularization [ Time Frame: 6-year ]
  10. Clinically-driven target-lesion revascularization [ Time Frame: 6-year ]
  11. Any coronary revascularization [ Time Frame: 6-year ]
  12. Any clinically-driven coronary revascularization [ Time Frame: 6-year ]
  13. Coronary artery bypass grafting [ Time Frame: 6-year ]
  14. Stroke [ Time Frame: 6-year ]
    Any ischemic and hemorrhagic strokes excluding transient ischemic attacks

  15. Worsening of angina due to coronary spasm [ Time Frame: 6-year ]
  16. Bleeding complications [ Time Frame: 6-year ]
    Bleeding complications defined by GUSTO and TIMI definitions

  17. Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization [ Time Frame: 6-year ]
  18. Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization [ Time Frame: 6-year ]
  19. Composite of cardiovascular death, myocardial infarction, stroke [ Time Frame: 6-year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155635


Locations
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Japan
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Takeshi Morimoto
Investigators
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Principal Investigator: Takeshi Kimura, MD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01155635    
Other Study ID Numbers: C-417
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
Myocardial infarction
Adrenergic beta-Antagonists
Percutaneous coronary intervention
Additional relevant MeSH terms:
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Myocardial Infarction
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
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists