NCT02681978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

February 4, 2016

Last Update Submit

February 10, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilation of the brachial artery

    8 weeks

Secondary Outcomes (3)

  • Number of patients with flow-mediated dilation of the brachial artery <7%

    8 weeks

  • Endothelium-independent dilation of the brachial artery

    8 weeks

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

    8 weeks

Study Arms (2)

Ivabradine group

ACTIVE COMPARATOR

Ivabradine 5 mg twice daily + standard medical therapy

Drug: IvabradineDrug: Standard medical therapy

Control group

OTHER

Standard medical therapy

Drug: Standard medical therapy

Interventions

IvabradineDRUG

Ivabradine 5 mg twice daily

Ivabradine group
Standard medical therapyDRUG

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

Control groupIvabradine group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • history of stable coronary disease
  • complete coronary revascularization with PCI at least 1 month prior to recruitment
  • sinus rhythm
  • absence of anginal symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Bio-Medico University

Rome, RM, 00128, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27520989DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Fabio Mangiacapra, MD, PhD

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Germano Di Sciascio

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 15, 2016

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations

IT(1)