Condition category
Circulatory System
Date applied
28/08/2009
Date assigned
21/09/2009
Last edited
20/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kim Fox

ORCID ID

Contact details

Sydney Street
London
SW3 6NP
United Kingdom

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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

20/09/2016: Publication reference added. 29/11/2012: The following changes were made to the trial record: 1. Armenia, Belarus, Georgia and the Philippines were added to the countries of recruitment. 2. The target number of participants was changed from 11330 to 16850. 3. The overall trial end date was changed from 31/03/2013 to 03/09/2013.