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

Primary Purpose

Coronary Disease, Ventricular Dysfunction, Left

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Ivabradine
Placebo
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brompton National Heart and Lung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ivabradine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cardiovascular Death
Cardiovascular death including sudden death of unknown cause
Hospitalisation for Acute Myocardial Infarction
Hospitalisation for New Onset or Worsening Heart Failure
All-cause of Mortality
Coronary Artery Disease Death
Death due to heart failure, acute myocardial infarction or cardiac procedure
Hospitalisation for Coronary Revascularisation
Hospitalisation for Unstable Angina
Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)
Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation
Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation
Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure
Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction

Full Information

First Posted
August 31, 2005
Last Updated
March 13, 2018
Sponsor
Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT00143507
Brief Title
The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut de Recherches Internationales Servier

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Ventricular Dysfunction, Left

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10917 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Primary Composite Endpoint
Description
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).
Time Frame
From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.
Secondary Outcome Measure Information:
Title
Cardiovascular Death
Description
Cardiovascular death including sudden death of unknown cause
Time Frame
From the date of randomisation to death, up to 3 years.
Title
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.
Title
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.
Title
All-cause of Mortality
Time Frame
From the date of randomisation to death, up to 3 years.
Title
Coronary Artery Disease Death
Description
Death due to heart failure, acute myocardial infarction or cardiac procedure
Time Frame
From the date of randomisation to death, up to 3 years.
Title
Hospitalisation for Coronary Revascularisation
Time Frame
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Title
Hospitalisation for Unstable Angina
Time Frame
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Fox, MD
Organizational Affiliation
Royal Brompton National Heart and Lung Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Brompton National Heart and Lung Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing 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.
IPD Sharing URL
http://clinicaltrials.servier.com
Citations:
PubMed Identifier
18757088
Citation
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.
Results Reference
result
Links:
URL
http://clinicaltrials.servier.com/wp-content/uploads/CL3-16257-056_synopsis_report.pdf
Description
Results summary

Learn more about this trial

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

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