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

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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