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

Servier

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Ivabradine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02446990

2009-011360-10 (EudraCT Number)

CL3-16257-083

Details and patient eligibility

About

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

Enrollment: 19,102 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19,102 participants in 2 patient groups, including a placebo group

Ivabradine

Experimental group

Treatment:

Drug: Ivabradine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo