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

Coronary Disease Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143507
• Other study ID #: CL3-16257-056
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: March 13, 2018
• Start date: December 2004
• Est. completion date: February 2008

Study information

• Verified date: March 2018
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10917
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• Ivabradine

• Placebo

Locations

Country	Name	City	State
United Kingdom	Royal Brompton National Heart and Lung Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Se — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.
Secondary	Cardiovascular Death	Cardiovascular death including sudden death of unknown cause	From the date of randomisation to death, up to 3 years.
Secondary	Hospitalisation for Acute Myocardial Infarction		From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Secondary	Hospitalisation for New Onset or Worsening Heart Failure		From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Secondary	All-cause of Mortality		From the date of randomisation to death, up to 3 years.
Secondary	Coronary Artery Disease Death	Death due to heart failure, acute myocardial infarction or cardiac procedure	From the date of randomisation to death, up to 3 years.
Secondary	Hospitalisation for Coronary Revascularisation		From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Secondary	Hospitalisation for Unstable Angina		From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Secondary	Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)		From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Secondary	Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation		From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Secondary	Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation		From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Secondary	Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure		From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Secondary	Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction		From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

External Links

•   Results summary