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

Information source: Kyoto University, Graduate School of Medicine
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction

Intervention: Carvedilol (Drug); No Carvedilol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Takeshi Morimoto

Official(s) and/or principal investigator(s):
Takeshi Kimura, MD, Principal Investigator, Affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Overall contact:
Takeshi Kimura, MD, Phone: +81-75-751-4254, Email: taketaka@kuhp.kyoto-u.ac.jp

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

All cause mortality

Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization

Secondary outcome:

Cardiac death

Sudden cardiac death

Cardiovascular death

Myocardial infarction

Acute coronary syndrome

Sustained ventricular tachycardia or ventricular fibrillation

Heart failure hospitalization

Stent thrombosis

Target-vessel revascularization

Clinically-driven target-lesion revascularization

Any coronary revascularization

Any clinically-driven coronary revascularization

Coronary artery bypass grafting

Stroke

Worsening of angina due to coronary spasm

Bleeding complications

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

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Takeshi Kimura, MD, Phone: +81-75-751-4254, Email: taketaka@kuhp.kyoto-u.ac.jp

Division of Cardiology, Kyoto University Hospital, Kyoto 606-8507, Japan; Recruiting
Takeshi Kimura, MD, Phone: +81-75-751-4254, Email: taketaka@kuhp.kyoto-u.ac.jp
Neiko Ozasa, MD, Phone: +81-75-751-4255, Email: nei126@kuhp.kyoto-u.ac.jp
Takeshi Kimura, MD, Principal Investigator
Additional Information

Starting date: July 2010
Last updated: December 21, 2012

Page last updated: February 07, 2013

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