Skip to main content
OpenTrials
Completed

NCT Number: NCT02681978

Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Campus Bio-Medico University

Rome, RM, 00128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivabradine

Drug

Ivabradine 5 mg twice daily

Standard Medical Therapy

Drug

Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions

Primary outcomes

  1. Flow-mediated dilation of the brachial artery

    Time frame: 8 weeks

Secondary outcomes

  1. Number of patients with flow-mediated dilation of the brachial artery <7%

    Time frame: 8 weeks

  2. Endothelium-independent dilation of the brachial artery

    Time frame: 8 weeks

    Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin

  3. Correlation between heart rate and flow-mediated dilation of the brachial artery

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study

Acronym: RIVENDEL

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 15, 2016
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.