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
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Ventricular Dysfunction, Left
Drug: Ivabradine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Servier:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 10917
Study Start Date: December 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ivabradine Drug: Ivabradine
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143507

Locations
United Kingdom
Royal Brompton National Heart and Lung Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
Study Chair: Kim Fox, MD Royal Brompton National Heart and Lung Hospital
  More Information

No publications provided by Servier

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00143507     History of Changes
Other Study ID Numbers: CL3-16257-056
Study First Received: August 31, 2005
Results First Received: May 13, 2015
Last Updated: June 22, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Ventricular Dysfunction
Ventricular Dysfunction, Left
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 30, 2015