Myocardial Infarction
Conditions
Keywords
Myocardial infarction, Adrenergic beta-Antagonists, Percutaneous coronary intervention
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.
Interventions
DRUGCarvedilol
Use of Carvedilol with any dose
DRUGNo Carvedilol
No use of Carvedilol
Sponsors
Takeshi Morimoto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 6-year | Death from any reason |
| Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization | 6-year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6-year | Stent thrombosis defined by Academic Research Consortium |
| Target-vessel revascularization | 6-year | — |
| Clinically-driven target-lesion revascularization | 6-year | — |
| Cardiac death | 6-year | — |
| Any clinically-driven coronary revascularization | 6-year | — |
| Coronary artery bypass grafting | 6-year | — |
| 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 | — |
| Any coronary revascularization | 6-year | — |
| Sudden cardiac death | 6-year | — |
Countries
Japan
Outcome results
None listed