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

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

January 5, 2006

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Composite endpoint including cardiovascular mortality, hospitalisation for acute myocardial infarction and for new onset or worsening heart failure.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00143507 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Composite and non-composite endpoints including hospitalisation for acute coronary syndrome, coronary revascularisation and mortality.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Coronary Disease
Ventricular Dysfunction, Left

Intervention ^ICMJE

Drug: Ivabradine

Study Arms / Comparison Groups

Publications *

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. Epub 2008 Aug 29.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

10000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kim Fox, MD

+44 207 351 86 26

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00143507

Responsible Party

Study ID Numbers ^ICMJE

CL3-16257-056

Study Sponsor ^ICMJE

Institut De Recherche International Servier

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Kim Fox, MD

Royal Brompton National Heart and Lung Hospital

Information Provided By

Servier

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP