Coronary Artery DiseasePhase 4RIVENDELNCT02681978
Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease
A Phase 4 study testing Ivabradine and Standard medical therapy in people with Coronary Artery Disease, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ivabradine and Standard medical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- history of stable coronary disease
- complete coronary revascularization with PCI at least 1 month prior to recruitment
- sinus rhythm
- absence of anginal symptoms
Who cannot join
- 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
Show all 9Show fewer
- sinoatrial block
- congenital long QT
- complete atrioventricular block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Ivabradine, Standard medical therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Ivabradine 5 mg twice daily
Standard medical therapyDrug
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine group | Active comparator | Ivabradine 5 mg twice daily + standard medical therapy Receives: Drug: Ivabradine; Drug: Standard medical therapy |
| Control group | Other | Standard medical therapy Receives: Drug: Standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation of the brachial artery
Measured: 8 weeks
Secondary outcomes (3)
Number of patients with flow-mediated dilation of the brachial artery <7%
Measured: 8 weeks
Endothelium-independent dilation of the brachial artery
Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin
Measured: 8 weeks
Correlation between heart rate and flow-mediated dilation of the brachial artery
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germano Di Sciascio, Campus Bio-Medico University
- Investigators
- Fabio Mangiacapra, MD, PhD, Principal investigator, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681978
- Sponsor's protocol ID
- RIVENDEL
- Acronym
- RIVENDEL
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study
- ClinicalTrials.gov ID
- NCT02681978
- Acronym / sponsor ID
- RIVENDEL / RIVENDEL
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine group | Active comparator | Drug: Ivabradine, Drug: Standard medical therapyIvabradine 5 mg twice daily + standard medical therapy |
| Control group | Other | Drug: Standard medical therapyStandard medical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- history of stable coronary disease
- complete coronary revascularization with PCI at least 1 month prior to recruitment
- sinus rhythm
- absence of anginal symptoms
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvabradineIvabradine 5 mg twice daily | Drug | Ivabradine group |
| Standard medical therapyStandard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions | Drug | Control group, Ivabradine group |
Primary outcome
Flow-mediated dilation of the brachial artery
Time frame: 8 weeks
3 secondary outcomes
Number of patients with flow-mediated dilation of the brachial artery <7%
Time frame: 8 weeks
Endothelium-independent dilation of the brachial artery
Time frame: 8 weeks
Correlation between heart rate and flow-mediated dilation of the brachial artery
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Derived from this study: PubMed 27520989Mangiacapra 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Mangiacapra, MD, PhD principal investigator
Campus Bio-Medico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine and Standard medical therapy in people with Coronary Artery Disease, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation of the brachial artery (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.