Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Ivabradine; Drug: Standard medical therapy

• Registration Number: NCT02681978
• Lead Sponsor: Campus Bio-Medico University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-02
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-10
• Last Update Submitted: 2016-02-10
• Study First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivabradine group	Standard medical therapy	Ivabradine 5 mg twice daily + standard medical therapy
Control group	Standard medical therapy	Standard medical therapy
Ivabradine group	Ivabradine	Ivabradine 5 mg twice daily + standard medical therapy

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation of the brachial artery	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Campus Bio-Medico University; 🇮🇹 Rome, RM, Italy