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

March 13, 2018 updated by: Institut de Recherches Internationales Servier

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10917

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton National Heart and Lung Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Ivabradine
Drug: Ivabradine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Death
Time Frame: From the date of randomisation to death, up to 3 years.
Cardiovascular death including sudden death of unknown cause
From the date of randomisation to death, up to 3 years.
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.
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
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.
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
All-cause of Mortality
Time Frame: From the date of randomisation to death, up to 3 years.
From the date of randomisation to death, up to 3 years.
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
From the date of randomisation to death, up to 3 years.
Hospitalisation for Coronary Revascularisation
Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for Unstable Angina
Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
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.
From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
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.
From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
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.
From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
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.
From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
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.
From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherches Internationales Servier

Investigators

  • Study Chair: Kim Fox, MD, Royal Brompton National Heart and Lung Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL3-16257-056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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