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Sponsored by: |
Hospital Universitario de Canarias |
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Information provided by: | Hospital Universitario de Canarias |
ClinicalTrials.gov Identifier: | NCT00815100 |
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
Condition | Intervention | Phase |
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Acute Coronary Syndromes |
Drug: Ivabradine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 1270 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator |
Drug: Placebo
Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).
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Ivabradine: Active Comparator |
Drug: Ivabradine
Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Ischemic symptoms suspected to represent a non-ST segment elevation acute coronary syndrome defined as:
Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occuring at rest or with minimal exertion (lasting longer than 10 min) and planned to be managed with an early invasive strategy with intention to perform a percutaneous coronary intervention as early as possible and not later than 72 hours of randomization, and at least one of the following:
Exclusion Criteria:
Patients with at least 1 of the following criteria:
Contact: Francisco Bosa-Ojeda, MD, PhD | +34 922 678457 | franbosa@ull.es |
Responsible Party: | Hospital Universitario de Canarias ( Francisco Bosa Ojeda ) |
Study ID Numbers: | Riviera/09 |
Study First Received: | December 25, 2008 |
Last Updated: | December 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00815100 |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
Ivabradine Acute coronary syndrome. Inflammation C-reactive protein Atherosclerosis |
Atherosclerosis Heart Diseases Myocardial Ischemia Acute Coronary Syndrome |
Vascular Diseases Ischemia Inflammation |
Pathologic Processes Disease Syndrome Cardiovascular Diseases |