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Completed

NCT Number: NCT00143507

The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Brompton National Heart and Lung Hospital

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Coronary artery disease
  • Left ventricular systolic dysfunction
  • Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)

Exclusion criteria

  • Unstable cardiovascular condition
  • Severe congestive heart failure

Treatment and study plan

Ivabradine

Drug

Placebo

Drug

Primary outcomes

  1. Primary Composite Endpoint

    Time frame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

    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).

Secondary outcomes

  1. Cardiovascular Death

    Time frame: From the date of randomisation to death, up to 3 years.

    Cardiovascular death including sudden death of unknown cause

  2. 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.

  3. 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.

  4. All-cause of Mortality

    Time frame: From the date of randomisation to death, up to 3 years.

  5. Coronary Artery Disease Death

    Time frame: From the date of randomisation to death, up to 3 years.

    Death due to heart failure, acute myocardial infarction or cardiac procedure

  6. Hospitalisation for Coronary Revascularisation

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.

  7. Hospitalisation for Unstable Angina

    Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Registry information

Official study title

Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-year Randomised Double-blind Placebo-controlled International Multicentre Study.

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 2, 2005
Registry last updated
Apr 12, 2018

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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