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Completed

NCT Number: NCT02446990

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivabradine

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. Primary Composite Endpoint

    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.

    First event among cardiovascular death or non-fatal myocardial infarction

Secondary outcomes

  1. All-cause Mortality

    Time frame: From the date of randomisation to death, up to 48 months

  2. Cardiovascular Mortality

    Time frame: From the date of randomisation to death, up to 48 months

    Component of the primary composite endpoint

  3. Coronary Mortality

    Time frame: From the date of randomisation to death, up to 48 months

    Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death

  4. Fatal Myocardial Infarction

    Time frame: From the date of randomisation to death, up to 48 months

    Non-composite secondary endpoint

  5. Non-fatal Myocardial Infarction

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Component of the primary composite endpoint

  6. Elective Coronary Revascularisation

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Non-composite secondary endpoint

  7. Coronary Revascularisation (Elective or Not)

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Non-composite secondary endpoint

  8. Secondary Composite Endpoint

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Fatal or non-fatal myocardial infarction

  9. Secondary Composite Endpoint

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Fatal or non-fatal myocardial infarction, coronary revascularisation

  10. Secondary Composite Endpoint

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina

  11. Secondary Composite Endpoint

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke

  12. Secondary Composite Endpoint

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Coronary death, non-fatal myocardial infarction

  13. Secondary Composite Endpoint

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months

    Non-fatal myocardial infarction, coronary revascularisation, unstable angina

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Registry information

Official study title

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

Acronym: SIGNIFY

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 18, 2015
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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