The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10,917
Royal Brompton National Heart and Lung Hospital
London, United Kingdom
Primary Composite Endpoint
First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).
Time frame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.
Cardiovascular Death
Cardiovascular death including sudden death of unknown cause
Time frame: From the date of randomisation to death, up to 3 years.
Hospitalisation for Acute Myocardial Infarction
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for New Onset or Worsening Heart Failure
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
All-cause of Mortality
Time frame: From the date of randomisation to death, up to 3 years.
Coronary Artery Disease Death
Death due to heart failure, acute myocardial infarction or cardiac procedure
Time frame: From the date of randomisation to death, up to 3 years.
Hospitalisation for Coronary Revascularisation
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for Unstable Angina
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
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Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)
Time frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation
Time frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation
Time frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure
Time frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction
Time frame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.