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

ISRCTN	ISRCTN61576291
DOI	https://doi.org/10.1186/ISRCTN61576291
EudraCT/CTIS number	2009-011360-10
ClinicalTrials.gov number	NCT02446990
Secondary identifying numbers	CL3-16257-083

Submission date: 28/08/2009
Registration date: 21/09/2009
Last edited: 10/09/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Kim Fox
Scientific

Sydney Street
London
SW3 6NP
United Kingdom

Study information

Study design	Randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	SIGNIFY
Study objectives	To evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	Coronary artery disease
Intervention	Ivabradine/placebo tablets for up to 48 months.
Intervention type	Other
Primary outcome measure	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 study start date	01/09/2009
Completion date	03/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	16850
Key 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
Key exclusion criteria	1. Unstable cardiovascular condition 2. Contra-indication to ivabradine
Date of first enrolment	01/09/2009
Date of final enrolment	03/09/2013

Locations

Countries of recruitment

Argentina
Armenia
Australia
Austria
Belarus
Belgium
Brazil
Bulgaria
Canada
China
Croatia
Czech Republic
Denmark
England
Estonia
Finland
France
Georgia
Germany
Greece
Hong Kong
Hungary
India
Ireland
Italy
Kazakhstan
Korea, South
Latvia
Lithuania
Malaysia
Mexico
Netherlands
North Macedonia
Norway
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Türkiye
Ukraine
United Kingdom
Uruguay
Viet Nam

Study participating centre

Sydney Street

London
SW3 6NP
United Kingdom

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	01/10/2013		Yes	No
Results article	results	18/09/2014		Yes	No
Results article	results	07/12/2015		Yes	No
Basic results			10/09/2019	No	No

Editorial Notes

10/09/2019: ClinicalTrials.gov number added. Added clinicaltrials.gov link to basic results (scientific).
28/03/2018: Publication plan and IPD sharing statement amended.
25/01/2018: Publication plan and IPD sharing statement added.
14/12/2017: Results summary added.
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.