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

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Placebo; Drug: Ivabradine

• Registration Number: NCT02446990
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Results First Submitted: 2015-05-20
• Results First Submitted QC: 2015-06-22
• Results First Posted: 2015-06-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19102

Inclusion Criteria

• Evidence of coronary artery disease
• Sinus rhythm and resting heart rate equal or higher than 70 bpm

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Exclusion Criteria

• Unstable cardiovascular condition
• Known hypersensitivity to ivabradine or current treatment with marketed ivabradine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ivabradine	Ivabradine	-

Primary Outcome Measures

Name	Time	Method
Primary Composite Endpoint	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.	First event among cardiovascular death or non-fatal myocardial infarction

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Azienda Ospedaliera Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

Royal Brompton Hospital; 🇬🇧 London, United Kingdom