Efectos de ivabradina en pacientes con arteriopatía coronaria estable sin insuficiencia cardíaca clínica. Estudio multicéntrico, internacional, aleatorizado, doble ciego, controlado con placeboStudy assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease (SIGNIFY)Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study.Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease (SIGNIFY) - SIGNIFY
Phase 1
- Conditions
- Arteriopatia Coronaria EstableStable coronary artery diseaseMedDRA version: 12.0Level: LLTClassification code 10011078Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2009-011360-10-ES
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 19102
Inclusion Criteria
- Pacientes con 55 años o mayores
- Hombres y mujer,
- Pacientes con arteriopatia coronaria sin insuficiencia cardiaca clínica,
- Ritmo sinusal y frecuencia cardiaca en reposo igual o mayor a 70 lpm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Condicion cardiovascular estable,
- Contraindicación de la administración de ivabradina o en tratamiento con ivabradina comercializada.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluar el efecto de ivabradina en eventos cardiovasculares en pacientes con arteriopatía coronaria;Secondary Objective: Eficacia y seguridad;Primary end point(s): Objetivocompuesto de mortalidad cardiovascular o infarto de miocardio no mortal
- Secondary Outcome Measures
Name Time Method