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

This study has been completed.
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00143507
First received: August 31, 2005
Last updated: June 22, 2015
Last verified: June 2015

August 31, 2005
June 22, 2015
December 2004
February 2008   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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).
Composite endpoint including cardiovascular mortality, hospitalisation for acute myocardial infarction and for new onset or worsening heart failure.
Complete list of historical versions of study NCT00143507 on ClinicalTrials.gov Archive Site
  • Cardiovascular Death [ Time Frame: From the date of randomisation to death, up to 3 years. ] [ Designated as safety issue: No ]
    Cardiovascular death including sudden death of unknown cause
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • All-cause of Mortality [ Time Frame: From the date of randomisation to death, up to 3 years. ] [ Designated as safety issue: No ]
  • Coronary Artery Disease Death [ Time Frame: From the date of randomisation to death, up to 3 years. ] [ Designated as safety issue: No ]
    Death due to heart failure, acute myocardial infarction or cardiac procedure
  • Hospitalisation for Coronary Revascularisation [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ] [ Designated as safety issue: No ]
  • Hospitalisation for Unstable Angina [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Composite and non-composite endpoints including hospitalisation for acute coronary syndrome, coronary revascularisation and mortality.
Not Provided
Not Provided
 
The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Disease
  • Ventricular Dysfunction, Left
  • Drug: Ivabradine
  • Drug: Placebo
  • Experimental: Ivabradine
    Intervention: Drug: Ivabradine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10917
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00143507
CL3-16257-056
Not Provided
Not Provided
Institut de Recherches Internationales Servier
Not Provided
Study Chair: Kim Fox, MD Royal Brompton National Heart and Lung Hospital
Servier
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP