Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. - SIGNIFY

• Conditions: Coronary artery disease; MedDRA version: 12.0Level: LLTClassification code 10011078Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2009-011360-10-GR
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-06
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 11330

Inclusion Criteria

- Aged 55 years or older,
- Male or female,
- Patients with stable coronary artery disease without clinical heart failure,
- Sinus rhythm and resting heart rate equal or higher than 70 bpm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Unstable cardiovascular condition,
- Contra-indications to the administration of ivabradine or current treatment with marketed ivabradine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.;Secondary Objective: Efficacy and safety.;Primary end point(s): Composite endpoint made of cardiovascular mortality or non fatal myocardial infarction.