Clinical trial NCT00143507: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Disease
Ventricular Dysfunction, Left
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 10917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Primary Composite Endpoint
timeFrame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.
Secondary outcomes:
measure: Cardiovascular Death
timeFrame: From the date of randomisation to death, up to 3 years.
measure: Hospitalisation for Acute Myocardial Infarction
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
measure: Hospitalisation for New Onset or Worsening Heart Failure
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
measure: All-cause of Mortality
timeFrame: From the date of randomisation to death, up to 3 years.
measure: Coronary Artery Disease Death
timeFrame: From the date of randomisation to death, up to 3 years.
measure: Hospitalisation for Coronary Revascularisation
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
measure: Hospitalisation for Unstable Angina
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
measure: Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)
timeFrame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
measure: Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation
timeFrame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
measure: Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation
timeFrame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
measure: Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure
timeFrame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
measure: Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction
timeFrame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton National Heart and Lung Hospital
Study officials:
affiliation: Royal Brompton National Heart and Lung Hospital
name: Kim Fox, MD
role: STUDY_CHAIR
References:
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.