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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine group | Active Comparator | Ivabradine 5 mg twice daily + standard medical therapy |
|
| Control group | Other | Standard medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine | Drug | Ivabradine 5 mg twice daily |
| |
| Standard medical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Flow-mediated dilation of the brachial artery | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with flow-mediated dilation of the brachial artery <7% | 8 weeks | |
| Endothelium-independent dilation of the brachial artery | Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Mangiacapra, MD, PhD | Campus Bio-Medico University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Bio-Medico University | Rome | RM | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27520989 | Derived | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions |
|
| 8 weeks |
| Correlation between heart rate and flow-mediated dilation of the brachial artery | 8 weeks |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |