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

Servier

Status and phase: Completed; Phase 3

Conditions: Ventricular Dysfunction, Left; Coronary Disease

Treatments: Drug: Ivabradine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00143507

CL3-16257-056

Details and patient eligibility

About

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.

Enrollment: 10,917 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10,917 participants in 2 patient groups, including a placebo group

Ivabradine

Experimental group

Treatment:

Drug: Ivabradine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo