Phase 3 N=10,917 Randomized Quadruple-blind Treatment

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

Coronary Disease · Ventricular Dysfunction, Left

Bottom Line

View on ClinicalTrials.gov: NCT00143507 ↗

Enrolled (actual)

10,917

Serious AEs

31.1%

Results posted

Jun 2015

Primary outcome: Primary: Primary Composite Endpoint — 844; 832 participants — p=0.945

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ivabradine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Institut de Recherches Internationales Servier
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Composite Endpoint	844; 832	0.945
SECONDARY Cardiovascular Death	469; 435	0.316
SECONDARY Hospitalisation for Acute Myocardial Infarction	199; 226	0.159
SECONDARY Hospitalisation for New Onset or Worsening Heart Failure	426; 427	0.850
SECONDARY All-cause of Mortality	572; 547	0.547
SECONDARY Coronary Artery Disease Death	136; 151	0.331
SECONDARY Hospitalisation for Coronary Revascularisation	155; 186	0.078
SECONDARY Hospitalisation for Unstable Angina	114; 105	0.583
SECONDARY Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)	303; 317	0.501
SECONDARY Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation	364; 401	0.141
SECONDARY Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation	681; 704	0.411
SECONDARY Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure	757; 723	0.484
SECONDARY Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction	606; 593	0.835

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00143507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.