Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure

Coronary Artery Disease Clinical Trial

— SIGNIFY  

Official title:

Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure. A Randomised Double-blind Placebo-controlled International Multicenter Study. Study Assessing the Morbi-mortality Benefits of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446990
• Other study ID #: CL3-16257-083
• Secondary ID: 2009-011360-10
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: January 2014

Study information

• Verified date: March 2020
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19102
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Evidence of coronary artery disease

• Sinus rhythm and resting heart rate equal or higher than 70 bpm

Exclusion Criteria:

• Unstable cardiovascular condition

• Known hypersensitivity to ivabradine or current treatment with marketed ivabradine

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Intervention

Drug:
• Ivabradine
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.
• Placebo
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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria di Ferrara	Ferrara
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

Italy,  United Kingdom, 

References & Publications (2)

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 ran — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause Mortality		From the date of randomisation to death, up to 48 months
Secondary	Cardiovascular Mortality	Component of the primary composite endpoint	From the date of randomisation to death, up to 48 months
Secondary	Coronary Mortality	Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death	From the date of randomisation to death, up to 48 months
Secondary	Fatal Myocardial Infarction	Non-composite secondary endpoint	From the date of randomisation to death, up to 48 months
Secondary	Non-fatal Myocardial Infarction	Component of the primary composite endpoint	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Elective Coronary Revascularisation	Non-composite secondary endpoint	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Coronary Revascularisation (Elective or Not)	Non-composite secondary endpoint	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Secondary Composite Endpoint	Fatal or non-fatal myocardial infarction	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Secondary Composite Endpoint	Fatal or non-fatal myocardial infarction, coronary revascularisation	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Secondary Composite Endpoint	Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Secondary Composite Endpoint	Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Secondary Composite Endpoint	Coronary death, non-fatal myocardial infarction	From the date of randomisation to the date of first occurrence of the event, up to 48 months
Secondary	Secondary Composite Endpoint	Non-fatal myocardial infarction, coronary revascularisation, unstable angina	From the date of randomisation to the date of first occurrence of the event, up to 48 months

External Links

•   Results summary