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

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: No Carvedilol; Drug: Carvedilol

• Registration Number: NCT01155635
• Lead Sponsor: Takeshi Morimoto

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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2015-06
• Study Completion: 2017-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-25
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 801

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non Beta-blocker	No Carvedilol	No use of Carvedilol
Beta-blocker	Carvedilol	Use of Carvedilol with any dose

Primary Outcome Measures

Name	Time	Method
All cause mortality	6-year	Death from any reason
Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization	6-year

Secondary Outcome Measures

Name	Time	Method
Target-vessel revascularization	6-year
Cardiac death	6-year
Sudden cardiac death	6-year
Heart failure hospitalization	6-year
Clinically-driven target-lesion revascularization	6-year
Any coronary revascularization	6-year
Any clinically-driven coronary revascularization	6-year
Coronary artery bypass grafting	6-year
Cardiovascular death	6-year
Acute coronary syndrome	6-year
Myocardial infarction	6-year
Sustained ventricular tachycardia or ventricular fibrillation	6-year
Stent thrombosis	6-year	Stent thrombosis defined by Academic Research Consortium
Stroke	6-year	Any ischemic and hemorrhagic strokes excluding transient ischemic attacks
Worsening of angina due to coronary spasm	6-year
Bleeding complications	6-year	Bleeding complications defined by GUSTO and TIMI definitions
Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization	6-year
Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization	6-year
Composite of cardiovascular death, myocardial infarction, stroke	6-year

Trial Locations

Locations (1)

Division of Cardiology, Kyoto University Hospital; 🇯🇵 Kyoto, Japan