Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease (RIVENDEL)

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Standard medical therapy; Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT02681978

RIVENDEL

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Ivabradine group

Active Comparator group

Description:

Ivabradine 5 mg twice daily + standard medical therapy

Treatment:

Drug: Ivabradine

Drug: Standard medical therapy

Control group

Other group

Description:

Standard medical therapy

Treatment:

Drug: Standard medical therapy