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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Carvedilol
* Drug: No Carvedilol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beta-blocker<br>Use of Carvedilol with any dose | Drug: Carvedilol<br>* Use of Carvedilol with any dose<br>|
| Active Comparator: Non Beta-blocker<br>No use of Carvedilol | Drug: No Carvedilol<br>* No use of Carvedilol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Death from any reason | 6-year | 
| Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization |  | 6-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 6-year | 
| Sudden cardiac death |  | 6-year | 
| Cardiovascular death |  | 6-year | 
| Myocardial infarction |  | 6-year | 
| Acute coronary syndrome |  | 6-year | 
| Sustained ventricular tachycardia or ventricular fibrillation |  | 6-year | 
| Heart failure hospitalization |  | 6-year | 
| Stent thrombosis | Stent thrombosis defined by Academic Research Consortium | 6-year | 
| Target-vessel revascularization |  | 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 | 
| Stroke | Any ischemic and hemorrhagic strokes excluding transient ischemic attacks | 6-year | 
| Worsening of angina due to coronary spasm |  | 6-year | 
| Bleeding complications | Bleeding complications defined by GUSTO and TIMI definitions | 6-year | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Adrenergic beta-Antagonists, Percutaneous coronary intervention