Clinical trial NCT02446990: Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 19102
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Primary Composite Endpoint
timeFrame: 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:
measure: All-cause Mortality
timeFrame: From the date of randomisation to death, up to 48 months
measure: Cardiovascular Mortality
timeFrame: From the date of randomisation to death, up to 48 months
measure: Coronary Mortality
timeFrame: From the date of randomisation to death, up to 48 months
measure: Fatal Myocardial Infarction
timeFrame: From the date of randomisation to death, up to 48 months
measure: Non-fatal Myocardial Infarction
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Elective Coronary Revascularisation
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Coronary Revascularisation (Elective or Not)
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Secondary Composite Endpoint
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Secondary Composite Endpoint
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Secondary Composite Endpoint
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Secondary Composite Endpoint
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Secondary Composite Endpoint
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
measure: Secondary Composite Endpoint
timeFrame: From the date of randomisation to the date of first occurrence of the event, up to 48 months
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria di Ferrara
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References:
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.
citation: 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 Oct;166(4):654-661.e6. doi: 10.1016/j.ahj.2013.06.024. Epub 2013 Sep 17.