Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ivabradine group

Ivabradine 5 mg twice daily + standard medical therapy

Group Type ACTIVE_COMPARATOR

Ivabradine

Intervention Type DRUG

Ivabradine 5 mg twice daily

Standard medical therapy

Intervention Type DRUG

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

Control group

Standard medical therapy

Group Type OTHER

Standard medical therapy

Intervention Type DRUG

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

Interventions

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Ivabradine

Ivabradine 5 mg twice daily

Intervention Type DRUG

Standard medical therapy

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

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No