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The SIGNIFY study

The SIGNIFY study. 19 102 patients, 51 countries, 1139 centers.

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The SIGNIFY study

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  1. The SIGNIFY study 19 102 patients, 51 countries, 1139 centers 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 Ifinhibitor 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;166:654-661.

  2. Study design Mean follow-up of 2.75 years 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 Ifinhibitor 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;166:654-661.

  3. Study population • Proven stable CAD • Age >55 years • Without LVSD (EF >40%, no clinical signs of HF) • In sinus rhythm, with a resting heart rate >70 bpm • Receiving appropriate stable conventional cardiovascular medication • With one or more other cardiovascular risk factors 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 Ifinhibitor 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;166:654-661.

  4. Study end points Primary composite end point Cardiovascular death or nonfatal myocardial infarction Secondary end points All-cause death Cardiovascular death Coronary death Nonfatal myocardial infarction Coronary revascularization Elective coronary revascularization New-onset or worsening heart failure 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 Ifinhibitor 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;166:654-661.

  5. Baseline characteristics Values are means  SD or n (%). 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 Ifinhibitor 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;166:654-661.

  6. Baseline characteristics 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 Ifinhibitor 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;166:654-661.

  7. Baseline characteristics 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 Ifinhibitor 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;166:654-661.

  8. Planned substudies • The Quality of Life Substudyis designed to evaluate changes in the Seattle Angina Questionnaire in 4500 patients with angina pectoris at baseline (CCS class II or higher), depending on the availability of an approved translation of the questionnaire. • The aim of the Biomarkers Substudyis to detect changes in circulating von Willebrand factor, as well as high-sensitivity troponin T and other biomarkers of CAD progression and endothelial function, in a group of 380 patients at baseline and at 3 and 12 months, in centers that meet the technical requirements. • The Pharmacogenomics Substudywill analyze whether genetic variations in candidate genes and in the whole genome are associated with clinical outcomes in about 5000 patients in countries where such studies receive ethical/regulatory approval. 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 Ifinhibitor 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;166:654-661.

  9. Official study website Read more about SIGNIFY at www.signify-study.com

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