Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure
NCT ID: NCT02446990
Last Updated: 2024-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
19102 participants
INTERVENTIONAL
2009-09-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ivabradine
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Sinus rhythm and resting heart rate equal or higher than 70 bpm
Exclusion Criteria
* Known hypersensitivity to ivabradine or current treatment with marketed ivabradine
55 Years
ALL
No
Sponsors
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Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Locations
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Azienda Ospedaliera Universitaria di Ferrara
Ferrara, , Italy
Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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2009-011360-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CL3-16257-083
Identifier Type: -
Identifier Source: org_study_id
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