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

NCT ID: NCT00143507

Last Updated: 2018-04-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10917 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-02-29

Brief Summary

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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

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Conditions

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Coronary Disease Ventricular Dysfunction, Left

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ivabradine

Group Type EXPERIMENTAL

Ivabradine

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ivabradine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherches Internationales Servier

OTHER

Sponsor Role lead

Principal Investigators

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Kim Fox, MD

Role: STUDY_CHAIR

Royal Brompton National Heart and Lung Hospital

Locations

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Royal Brompton National Heart and Lung Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 18757088 (View on PubMed)

Other Identifiers

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CL3-16257-056

Identifier Type: -

Identifier Source: org_study_id

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