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Completed

NCT Number: NCT01155635

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol

Drug

Use of Carvedilol with any dose

No Carvedilol

Drug

No use of Carvedilol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Takeshi Morimoto

Other

Registry information

Official study title

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

Acronym: CAPITAL-RCT

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Jul 2, 2010
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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