Phase 3 N=19,102 Randomized Quadruple-blind Treatment

Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT02446990 ↗

Enrolled (actual)

19,102

Serious AEs

34.8%

Results posted

Jun 2015

Primary outcome: Primary: Primary Composite Endpoint — 654; 611 participants — p=0.1969

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ivabradine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Institut de Recherches Internationales Servier
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Composite Endpoint	654; 611	0.1969
SECONDARY All-cause Mortality	485; 458	0.3461
SECONDARY Cardiovascular Mortality	329; 301	0.2493
SECONDARY Coronary Mortality	263; 249	0.5162
SECONDARY Fatal Myocardial Infarction	51; 38	0.1647
SECONDARY Non-fatal Myocardial Infarction	351; 339	0.6024
SECONDARY Elective Coronary Revascularisation	270; 305	0.1458
SECONDARY Coronary Revascularisation (Elective or Not)	562; 564	0.9790
SECONDARY Secondary Composite Endpoint	734; 759	0.5285
SECONDARY Secondary Composite Endpoint	734; 759	0.5285
SECONDARY Secondary Composite Endpoint	734; 759	0.5285
SECONDARY Secondary Composite Endpoint	734; 759	0.5285
SECONDARY Secondary Composite Endpoint	734; 759	0.5285
SECONDARY Secondary Composite Endpoint	734; 759	0.5285

Summary

The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

Eligibility Criteria

Inclusion Criteria

Evidence of coronary artery disease
Sinus rhythm and resting heart rate equal or higher than 70 bpm

Exclusion Criteria

Unstable cardiovascular condition
Known hypersensitivity to ivabradine or current treatment with marketed ivabradine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02446990). 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.