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Study 15 of 2431 for search of: | received on or after 11/14/2008 |
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Brief Title † | Effects of the Ivabradine on Reduction of Inflammatory Markers in Patients With Acute Coronary Syndrome | ||||
Official Title † | Randomised, Double-Blind, Placebo-Controlled Trial of IVabradine in Patients With Acute Coronary Syndrome: Effects of the If Current Inhibitor Ivabradine or rEduction of Inflammation maRkers in Patients With Acute Coronary Syndrome | ||||
Brief Summary | The purpose of this study is to investigate whether a pure heart rate-lowering agent (Ivabradine) reduces vascular inflammatory stress in patients with acute coronary syndromes |
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Detailed Description | The activation of inflammatory pathways plays an important contributory role in coronary plaque instability and subsequent rupture, which can lead to the development of acute coronary syndromes. Elevated levels of serum inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP) represent independent risk factors for further cardiovascular events. Raised resting heart rate (HR) has been shown to be associated with cardiovascular events. Ivabradine is a new HR-reducing agent, which has demonstrated antianginal and anti-ischemic properties in patients with stable angina. In an atherosclerosis model, selective HR reduction with ivabradine has been shown to decrease markers of vascular oxidative stress, to improve endothelial function, and to reduce atherosclerotic plaque formation. We hypothesized that the addition of ivabradine to standard medical therapy has a beneficial effect on markers of inflammatory stress in acute coronary syndrome patients. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
Primary Outcome Measure † | Whether initiation of ivabradine therapy in patients with acute coronary syndromes immediately after hospital admission decreases high-sensitivity C-reactive protein. [ Time Frame: day 4 and day 30 ] [ Designated as safety issue: Yes ] | ||||
Secondary Outcome Measure † | Whether initiation of ivabradine therapy decreases the occurrence of ischemic events (death, nonfatal myocardial infarction, unstable angina, urgent revascularization, cardiac arrest) in patients with acute coronary syndromes. [ Time Frame: day 30, 90, 180 and 360 ] [ Designated as safety issue: Yes ] | ||||
Condition † | Acute Coronary Syndromes | ||||
Intervention † | Drug: Ivabradine Drug: Placebo |
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Recruitment Information Fields | |||||
Recruitment Status † | Not yet recruiting | ||||
Enrollment † | 1270 | ||||
Start Date † | April 2009 | ||||
Completion Date | April 2012 | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
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Administrative Information Fields | |||||
NCT ID † | NCT00815100 | ||||
Organization ID | Riviera/09 | ||||
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Study Sponsor † | Hospital Universitario de Canarias | ||||
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Information Provided By | Hospital Universitario de Canarias | ||||
Verification Date | December 2008 | ||||
First Received Date † | December 25, 2008 | ||||
Last Updated Date | December 26, 2008 |