Effects of ivabradine in patients with stable coronary artery disease without heart failure
| ISRCTN | ISRCTN61576291 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61576291 |
| ClinicalTrials.gov (NCT) | NCT02446990 |
| Clinical Trials Information System (CTIS) | 2009-011360-10 |
| Protocol serial number | CL3-16257-083 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Sydney Street
London
SW3 6NP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
The effect of ivabradine on cardiovascular events, measured up to 48 months. |
| Key secondary outcome measure(s) |
Measured up to 48 months: |
| Completion date | 03/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- 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
- 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
- Uruguay
- Viet Nam
Study participating centre
SW3 6NP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| 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 | No | No | |||
| Basic results | 10/09/2019 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
