Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— RIVENDEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681978
• Other study ID #: RIVENDEL
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2016
• Last updated: February 10, 2016
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ivabradine
Ivabradine 5 mg twice daily
• Standard medical therapy
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions

Locations

Country	Name	City	State
Italy	Campus Bio-Medico University	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation of the brachial artery		8 weeks	No
Secondary	Number of patients with flow-mediated dilation of the brachial artery <7%		8 weeks	No
Secondary	Endothelium-independent dilation of the brachial artery	Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin	8 weeks	No
Secondary	Correlation between heart rate and flow-mediated dilation of the brachial artery		8 weeks	No