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.

Institut de Recherches Internationales Servier1 site in 1 country10,917 target enrollmentDecember 2004

ConditionsCoronary Disease Ventricular Dysfunction, Left

InterventionsIvabradine Placebo

DrugsIvabradine Placebo

Overview

Phase: Phase 3
Intervention: Ivabradine
Conditions: Coronary Disease
Sponsor: Institut de Recherches Internationales Servier
Enrollment: 10917
Locations: 1
Primary Endpoint: Primary Composite Endpoint
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

February 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut de Recherches Internationales Servier

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

Arms & Interventions

Ivabradine

Intervention: Ivabradine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Primary Composite Endpoint

Time Frame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).

Secondary Outcomes

Coronary Artery Disease Death(From the date of randomisation to death, up to 3 years.)
All-cause of Mortality(From the date of randomisation to death, up to 3 years.)
Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
Hospitalisation for Acute Myocardial Infarction(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
Hospitalisation for New Onset or Worsening Heart Failure(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation(From the date of randomisation to the date of first occurrence of the first event, up to 3 years.)
Cardiovascular Death(From the date of randomisation to death, up to 3 years.)
Hospitalisation for Coronary Revascularisation(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
Hospitalisation for Unstable Angina(From the date of randomisation to the date of first occurrence of the event, up to 3 years.)
Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction(From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.)