Additional identifiers
EudraCT number
2009-011360-10
ClinicalTrials.gov number
Protocol/serial number
CL3-16257-083
Study information
Scientific title
Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure: a randomised double-blind placebo-controlled international multicentre study
Acronym
SIGNIFY
Study hypothesis
To evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Coronary artery disease
Intervention
Ivabradine/placebo tablets for up to 48 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The effect of ivabradine on cardiovascular events, measured up to 48 months.
Secondary outcome measures
Measured up to 48 months:
1. Efficacy
2. Safety
Overall trial start date
01/09/2009
Overall trial end date
03/09/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 55 years or older
2. Male or female
3. Patients with stable coronary artery disease without clinical heart failure
4. Sinus rhythm and resting heart rate equal or higher than 70 bpm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16850
Participant exclusion criteria
1. Unstable cardiovascular condition
2. Contra-indication to ivabradine
Recruitment start date
01/09/2009
Recruitment end date
03/09/2013
Locations
Countries of recruitment
Argentina, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Kazakhstan, Korea, South, Latvia, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Viet Nam
Trial participating centre
Sydney Street
London
SW3 6NP
United Kingdom
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-16257-083_synopsis_report.pdf
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24093844
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25176136
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26385957
Publication citations
-
Results
Fox K, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R, Rationale, design, and baseline characteristics of the Study assessInG the morbidity-mortality beNefits of the If inhibitor ivabradine in patients with coronarY artery disease (SIGNIFY trial): a randomized, double-blind, placebo-controlled trial of ivabradine in patients with stable coronary artery disease without clinical heart failure., Am. Heart J., 2013, 166, 4, 654-661.e6, doi: 10.1016/j.ahj.2013.06.024.
-
Results
Fox K, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R, , Ivabradine in stable coronary artery disease without clinical heart failure., N. Engl. J. Med., 2014, 371, 12, 1091-1099, doi: 10.1056/NEJMoa1406430.