Coronary Artery Disease
Conditions
Brief summary
This study evaluates the effect of ivabradine on endothelial function in patients with coronary artery disease (CAD) after complete revascularization with percutaneous coronary angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive ivabradine 5 mg twice daily or to continue with standard medical therapy.
Interventions
DRUGIvabradine
Ivabradine 5 mg twice daily
DRUGStandard medical therapy
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* history of stable coronary disease * complete coronary revascularization with PCI at least 1 month prior to recruitment * sinus rhythm * absence of anginal symptoms
Exclusion criteria
* resting heart rate \<60 beats per minute * severe reduction of left ventricle ejection fraction (\<40%) * coronary artery by-pass surgery * myocardial infarction, stroke or cerebral transient ischemic attack within the previous 6 months * implanted pacemaker, cardioverter, or defibrillator * sick sinus syndrome * sinoatrial block * congenital long QT * complete atrioventricular block
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-mediated dilation of the brachial artery | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with flow-mediated dilation of the brachial artery <7% | 8 weeks | — |
| Endothelium-independent dilation of the brachial artery | 8 weeks | Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin |
| Correlation between heart rate and flow-mediated dilation of the brachial artery | 8 weeks | — |
Countries
Italy
Outcome results
None listed