The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19,102
5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
Royal Brompton Hospital
London, United Kingdom
Primary Composite Endpoint
First event among cardiovascular death or non-fatal myocardial infarction
Time frame: The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.
All-cause Mortality
Time frame: From the date of randomisation to death, up to 48 months
Cardiovascular Mortality
Component of the primary composite endpoint
Time frame: From the date of randomisation to death, up to 48 months
Coronary Mortality
Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death
Time frame: From the date of randomisation to death, up to 48 months
Fatal Myocardial Infarction
Non-composite secondary endpoint
Time frame: From the date of randomisation to death, up to 48 months
Non-fatal Myocardial Infarction
Component of the primary composite endpoint
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Elective Coronary Revascularisation
Non-composite secondary endpoint
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
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Coronary Revascularisation (Elective or Not)
Non-composite secondary endpoint
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary Composite Endpoint
Fatal or non-fatal myocardial infarction
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary Composite Endpoint
Fatal or non-fatal myocardial infarction, coronary revascularisation
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary Composite Endpoint
Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary Composite Endpoint
Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary Composite Endpoint
Coronary death, non-fatal myocardial infarction
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary Composite Endpoint
Non-fatal myocardial infarction, coronary revascularisation, unstable angina
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months