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Clinical Trials/NCT02446990
NCT02446990CompletedPhase 3

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

Institut de Recherches Internationales Servier2 sites in 2 countries19,102 target enrollmentStarted: September 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
19,102
Locations
2
Primary Endpoint
Primary Composite Endpoint
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Ivabradine

Experimental

Intervention: Ivabradine (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Primary Composite Endpoint

Time Frame: 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 Outcomes

  • Cardiovascular Mortality(From the date of randomisation to death, up to 48 months)
  • Elective Coronary Revascularisation(From the date of randomisation to the date of first occurrence of the event, up to 48 months)
  • Secondary Composite Endpoint(From the date of randomisation to the date of first occurrence of the event, up to 48 months)
  • 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-fatal Myocardial Infarction(From the date of randomisation to the date of first occurrence of the event, up to 48 months)
  • Coronary Revascularisation (Elective or Not)(From the date of randomisation to the date of first occurrence of the event, up to 48 months)
  • Coronary Mortality(From the date of randomisation to death, up to 48 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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