Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011360-10-PT

Enrollment

16850

Registered

2009-08-07

Start date

2009-10-02

Completion date

Unknown

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease MedDRA version: 14.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: PROCORALAN Product Name: S16257 Product Code: S16257 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257-2 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7950

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.;Timepoint(s) of evaluation of this end point: Composite endpoint measured up to 42 months	—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy and safety endpoints;Timepoint(s) of evaluation of this end point: Efficacy and safety endpoints measured up to 42 months	—

Countries

Argentina, Armenia, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Democratic People's Republic of, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Vietnam

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com33155724366

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026