Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

Official Title
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Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure. A Randomised Double-blind Placebo-controlled International Multicenter Study. Study Assessing the Morbi-mortality Benefits of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Ivabradine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of coronary artery disease Sinus rhythm and resting heart rate equal or higher than 70 bpm Exclusion Criteria: Unstable cardiovascular condition Known hypersensitivity to ivabradine or current treatment with marketed ivabradine

Ages Eligible for Study
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Minimum Age: 55 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivabradine<br> | Drug: Ivabradine<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Composite Endpoint | First event among cardiovascular death or non-fatal myocardial infarction | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality |  | From the date of randomisation to death, up to 48 months | 
| Cardiovascular Mortality | Component of the primary composite endpoint | 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 | From the date of randomisation to death, up to 48 months | 
| Fatal Myocardial Infarction | Non-composite secondary endpoint | From the date of randomisation to death, up to 48 months | 
| Non-fatal Myocardial Infarction | Component of the primary composite endpoint | 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 | From the date of randomisation to the date of first occurrence of the event, up to 48 months | 
| Coronary Revascularisation (Elective or Not) | Non-composite secondary endpoint | 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 | 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 | 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 | 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 | 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 | 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 | From the date of randomisation to the date of first occurrence of the event, up to 48 months |