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CompletedNCT02681978RIVENDELUpdated Feb 15, 2016

Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

A Phase 4 interventional study of Ivabradine and Standard medical therapy in Coronary Artery Disease, sponsored by Campus Bio-Medico University. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2016-02-15.

Sponsored by Campus Bio-Medico University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Sex
All
01

Study 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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 70 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 84 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Ivabradine group

    Ivabradine 5 mg twice daily + standard medical therapy

    Drug: Ivabradine · Drug: Standard medical therapy

  • Other
    Control group

    Standard medical therapy

    Drug: Standard medical therapy

Interventions

  • DrugIvabradine

    Ivabradine 5 mg twice daily

  • DrugStandard medical therapy

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

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What researchers measure

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

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

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Study locations

1 site
  • Campus Bio-Medico University
    Rome, RM 00128, Italy
08

References and documents

Publications

  • Mangiacapra F, Colaiori I, Ricottini E, Balducci F, Creta A, Demartini C, Minotti G, Di Sciascio G. Heart Rate reduction by IVabradine for improvement of ENDothELial function in patients with coronary artery disease: the RIVENDEL study. Clin Res Cardiol. 2017 Jan;106(1):69-75. doi: 10.1007/s00392-016-1024-7. Epub 2016 Aug 12. PubMed 27520989 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02681978
Lead sponsor
Campus Bio-Medico University
Responsible party
Germano Di Sciascio (Prof. Germano Di Sciascio, Campus Bio-Medico University) — Principal investigator
First posted
Feb 15, 2016
Start date
Feb 2014
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Feb 15, 2016

Study contacts

Fabio Mangiacapra, MD, PhD
principal investigator · Campus Bio-Medico University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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