the slide set

advertisement
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 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;166:654-661.
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 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;166:654-661.
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 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;166:654-661.
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 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;166:654-661.
Baseline characteristics
Whole population
(N = 19 102)
Demographic characteristics
Age (y)
<70
≥70
≥75
Body mass index (kg/m2)
Heart rate (beats/min)
Male
Ethnic origin
White
Asian
Other
Systolic blood pressure (mm Hg)
Diastolic blood pressure (mm Hg)
CAD duration (y)
65.0 ± 7.2
13 669 (72)
5433 (28)
2227 (12)
28.8 ± 4.6
77.2 ± 7.0
13 840 (72)
15 532 (81)
2547 (13)
1022 (5)
130.5 ± 13.6
78.2 ± 8.2
6.2 ± 6.3
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 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;166:654-661.
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 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;166:654-661.
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 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;166:654-661.
Planned substudies
• The Quality of Life Substudy is 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 Substudy is 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 Substudy will 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 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;166:654-661.
Official study website
Read more about SIGNIFY at
www.signify-study.com
Download
Related flashcards

Heart diseases

42 cards

Cardiac arrhythmia

57 cards

Create Flashcards