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

• Sponsor: Campus Bio-Medico University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02681978
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 16.9
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Ivabradine; Drug: Standard medical therapy	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ivabradine group Ivabradine 5 mg twice daily + standard medical therapy	Drug: Ivabradine; Ivabradine 5 mg twice daily; Drug: Standard medical therapy; Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Other: Control group Standard medical therapy	Drug: Standard medical therapy; Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions

Outcome Measures

Primary Outcome Measures

1. Flow-mediated dilation of the brachial artery [8 weeks]

Secondary Outcome Measures

1. Number of patients with flow-mediated dilation of the brachial artery <7% [8 weeks]

2. Endothelium-independent dilation of the brachial artery [8 weeks]

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

3. Correlation between heart rate and flow-mediated dilation of the brachial artery [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Campus Bio-Medico University	Rome	RM	Italy	00128

Sponsors and Collaborators

• Campus Bio-Medico University

Investigators

• Principal Investigator: Fabio Mangiacapra, MD, PhD, Campus Bio-Medico University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Germano Di Sciascio, Prof. Germano Di Sciascio, Campus Bio-Medico University
• ClinicalTrials.gov Identifier: NCT02681978
• Other Study ID Numbers: RIVENDEL
• First Posted: Feb 15, 2016
• Last Update Posted: Feb 15, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Feb 15, 2016