- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02681978
Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease (RIVENDEL)
February 10, 2016 updated by: Germano Di Sciascio, Campus Bio-Medico University
Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RM
-
Rome, RM, Italy, 00128
- Campus Bio-Medico University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ivabradine group
Ivabradine 5 mg twice daily + standard medical therapy
|
Ivabradine 5 mg twice daily
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
|
Other: Control group
Standard medical therapy
|
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Flow-mediated dilation of the brachial artery
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with flow-mediated dilation of the brachial artery <7%
Time Frame: 8 weeks
|
8 weeks
|
|
Endothelium-independent dilation of the brachial artery
Time Frame: 8 weeks
|
Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin
|
8 weeks
|
Correlation between heart rate and flow-mediated dilation of the brachial artery
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabio Mangiacapra, MD, PhD, Campus Bio-Medico University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
February 4, 2016
First Submitted That Met QC Criteria
February 10, 2016
First Posted (Estimate)
February 15, 2016
Study Record Updates
Last Update Posted (Estimate)
February 15, 2016
Last Update Submitted That Met QC Criteria
February 10, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIVENDEL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Ivabradine
-
Assistance Publique - Hôpitaux de ParisRecruiting
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Asan Medical CenterInstitut de Recherches Internationales ServierCompletedHealthy IndividualKorea, Republic of
-
University of California, San DiegoAmgenCompletedPostural Orthostatic Tachycardia SyndromeUnited States
-
Institut de Recherches Internationales ServierCompleted
-
Institut de Recherches Internationales ServierCompletedCoronary Disease | Ventricular Dysfunction, LeftUnited Kingdom
-
Medical University of WarsawUnknown
-
Qian gengRecruiting
-
Institut de Recherches Internationales ServierCompletedHeart Failure, CongestiveItaly
-
Tel-Aviv Sourasky Medical CenterUnknownPostural Tachycardia Syndrome
-
Kanecia Obie ZimmermanEnrolling by invitationLong COVID | Long Covid19 | Long Covid-19United States