Fluvastatin in the therapy of acute coronary syndrome: Rationale and design of a multicenter, randomized, double-blind, placebo-controlled trial (The FACS Trial)[ISRCTN81331696]
| Autor: | Jiri Kettner, Petr Hájek, Milan Macek, Martin Wiendl, Josef Veselka, Jana Cepova, Martin Mates, Jiri Vejvoda, Eduard Nemecek, Peter Blaško, Petr Ostadal, Ondrej Aschermann, David Alan, Josef Slaby, Marek Rac, Frantisek Holm, Milan Kvapil |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
medicine.medical_specialty
Acute coronary syndrome Statin medicine.drug_class fluvastatin Placebo-controlled study interleukin 6 acute coronary syndrome C-reactive protein pregnancy-associated plasma protein A chemistry.chemical_compound Internal medicine medicine lcsh:R5-920 biology Cholesterol business.industry Research statin Cerivastatin medicine.disease Clinical trial chemistry biology.protein Physical therapy business lcsh:Medicine (General) Cardiology and Cardiovascular Medicine Fluvastatin medicine.drug |
| Zdroj: | Current Controlled Trials in Cardiovascular Medicine, Vol 6, Iss 1, p 4 (2005) Current Controlled Trials in Cardiovascular Medicine |
| ISSN: | 1468-6708 |
| DOI: | 10.1186/1468-6708-6-4 |
| Popis: | BackgroundActivation of inflammatory pathways plays an important contributory role in coronary plaque instability and subsequent rupture, which can lead to the development of acute coronary syndrome (ACS). Elevated levels of serum inflammatory markers such as C-reactive protein (CRP) represent independent risk factors for further cardiovascular events. Recent evidence indicates that in addition to lowering cholesterol levels, statins also decrease levels of inflammatory markers. Previous controlled clinical trials reporting the positive effects of statins in participants with ACS were designed for very early secondary prevention. To our knowledge, no controlled trials have evaluated the potential benefits of statin therapy, beginning immediately at the time of hospital admission. A previous pilot study performed by our group focused on early initiation of cerivastatin therapy. We demonstrated a highly significant reduction in levels of inflammatory markers (CRP and interleukin-6). Based on these preliminary findings, we are conducting a clinical trial to evaluate the efficacy of another statin, fluvastatin, as an early intervention in patients with ACS.MethodsThe FACS-trial (Fluvastatin in the therapy of Acute Coronary Syndrome) is a multicenter, randomized, double-blind, placebo-controlled study evaluating the effects of fluvastatin therapy initiated at the time of hospital admission. The study will enroll 1,000 participants admitted to hospital for ACS (both with and without ST elevation). The primary endpoint for the study is the influence of fluvastatin therapy on levels of inflammatory markers (CRP and interleukin-6) and on pregnancy associated plasma protein A (PAPP-A). A combined secondary endpoint is 30-day and one-year occurrence of death, nonfatal myocardial infarction, recurrent symptomatic ischemia, urgent revascularization, and cardiac arrest.ConclusionThe primary objective of the FACS trial is to demonstrate that statin therapy, when started immediately after hospital admission for ACS, results in reduction of inflammation and improvement of prognosis. This study may contribute to new knowledge regarding therapeutic strategies for patients suffering from ACS and may offer additional clinical indications for the use of statins. |
| Databáze: | OpenAIRE |
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