Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure
SIGNIFY
2 other identifiers
interventional
19,102
2 countries
2
Brief Summary
The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Sep 2009
Typical duration for phase_3 coronary-artery-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 5, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedResults Posted
Study results publicly available
June 25, 2015
CompletedJuly 26, 2024
July 1, 2024
4.3 years
May 5, 2015
May 20, 2015
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Composite Endpoint
First event among cardiovascular death or non-fatal myocardial infarction
The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.
Secondary Outcomes (13)
All-cause Mortality
From the date of randomisation to death, up to 48 months
Cardiovascular Mortality
From the date of randomisation to death, up to 48 months
Coronary Mortality
From the date of randomisation to death, up to 48 months
Fatal Myocardial Infarction
From the date of randomisation to death, up to 48 months
Non-fatal Myocardial Infarction
From the date of randomisation to the date of first occurrence of the event, up to 48 months
- +8 more secondary outcomes
Study Arms (2)
Ivabradine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Eligibility Criteria
You may qualify if:
- Evidence of coronary artery disease
- Sinus rhythm and resting heart rate equal or higher than 70 bpm
You may not qualify if:
- Unstable cardiovascular condition
- Known hypersensitivity to ivabradine or current treatment with marketed ivabradine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, 44100, Italy
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Related Publications (2)
Fox K, Ford I, Steg PG, Tardif JC, Tendera M, Ferrari R; SIGNIFY Investigators. Ivabradine in stable coronary artery disease without clinical heart failure. N Engl J Med. 2014 Sep 18;371(12):1091-9. doi: 10.1056/NEJMoa1406430. Epub 2014 Aug 31.
PMID: 25176136RESULTFox 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 Oct;166(4):654-661.e6. doi: 10.1016/j.ahj.2013.06.024. Epub 2013 Sep 17.
PMID: 24093844RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Innovation Pole
- Organization
- Institut de Recherches Internationales Servier (I.R.I.S.)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2015
First Posted
May 18, 2015
Study Start
September 1, 2009
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
July 26, 2024
Results First Posted
June 25, 2015
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.