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

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ClinicalTrials.gov Identifier: NCT00143507
Recruitment Status : Completed
First Posted : September 2, 2005
Results First Posted : June 25, 2015
Last Update Posted : April 12, 2018
Sponsor:
Information provided by:
Servier

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Disease Ventricular Dysfunction, Left Drug: Ivabradine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10917 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : December 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ivabradine Drug: Ivabradine
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Results summary  This link exits the ClinicalTrials.gov site

Publications of Results:

ClinicalTrials.gov Identifier: NCT00143507     History of Changes
Other Study ID Numbers: CL3-16257-056
First Posted: September 2, 2005    Key Record Dates
Results First Posted: June 25, 2015
Last Update Posted: April 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com

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