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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 15, 2011
Last verified: June 2011
History of Changes
  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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by Servier:

Primary Outcome Measures:
  • Composite endpoint including cardiovascular mortality, hospitalisation for acute myocardial infarction and for new onset or worsening heart failure.

Secondary Outcome Measures:
  • Composite and non-composite endpoints including hospitalisation for acute coronary syndrome, coronary revascularisation and mortality.

Estimated Enrollment: 10000
Study Start Date: December 2004
Study Completion Date: February 2008
  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
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
Last Updated: June 15, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013