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Accordingly, we designed the ASTEROID trial (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary. The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce . statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound- Derived Coronary Atheroma Burden – ASTEROID. Mar 13, Share via: AddThis.

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Our website uses cookies to enhance your experience. Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease in symptomatic men with normal to moderately elevated serum cholesterol levels: Cardiologia Ospedale Civile, Venezia B.

Most atherosclerosis trials have demonstrated that active lipid-modulating therapy, primarily using statin drugs, can reduce the rate of disease progression. Designing a contemporary IVUS regression-progression trial creates major challenges that warrant further comment.

Effects of AGI and probucol after percutaneous coronary interventions. All 3 efficacy parameters showed statistically significant regression. Nissen, Nicholls, Schoenhagen, Crowe, Tuzcu.

Effects of the acyl coenzyme A: All patients were statin-naive, defined as receiving no statin therapy for more than 3 months during the previous 12 months. Adverse events were infrequent and similar to other statin trials.

The ASTEROID trial: coronary plaque regression with high-dose statin therapy.

Monitoring of the study and maintenance of the trial database was performed by a contract research organization, Qsteroid, under contract to the sponsor. The current study suggests that there is potential for a more optimistic strategy, in which aggressive lipid-modulating strategies can actually reverse the atherosclerotic disease process.

The protocol specified enrollment of patients at least 18 years of age who required coronary angiography for a rosuvsstatin indication, which typically consisted of stable or unstable ischemic chest pain syndromes or abnormal functional studies, such as exercise testing.

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After he received a nonsteroidal anti-inflammatory agent, renal failure developed, the family declined dialysis, and the patient died 5 days later.

Atherosclerosis is generally viewed as a chronic, progressive disease characterized by continuous accumulation of atheromatous plaque within the arterial wall. The achieved LDL-C levels were the lowest values ever observed in a statin atherosclerosis progression trial, and the magnitude of the HDL-C increase also exceeded effects reported in previous statin trials.

Traditional thinking has viewed atherosclerosis as an inexorably progressive disease for which even the most active therapies can merely slow advancement. Of the patients who were not triial in the IVUS analysis, 14 were lost to follow-up, 2 were withdrawn per investigator discretion, 3 were withdrawn for protocol violations, 32 patients withdrew consent, 63 were withdrawn for an adverse event, and asteroi withdrew for other reasons.

Normalized TAV for each patient was calculated as the average atheroma area multiplied by the median number of comparable cross-sections in pullbacks for all patients completing the trial. Rosuvaastatin for Sequence Concealment.

The change in the mm segment with the most severe disease is analogous to the methods used by investigators who examined only short segments with visible angiographic disease. Analyses were performed using SAS software, roduvastatin 8.

The magnitude and consistency of regression observed in the current trial are noteworthy. The number of clinical events in this month trial was too small for any meaningful analysis of the relationship between progression rate and morbidity or mortality.

The institutional review boards of all participating centers approved the protocol and all patients provided written informed consent.

Analysis and interpretation of data: We compensated for the absence of placebo controls by blinding date information on IVUS studies and resequencing the examinations to eliminate observer bias in interpretation.

Thirty-three patients did not have a final IVUS result analyzed, 13 of whom did not undergo a final IVUS examination and 20 of whom had IVUS results that were not analyzable because of artifacts or pullbacks shorter than the prespecified mm minimum length. Get free access to newly published articles Create a personal account or sign in to: A safety analysis was performed in all patients who received at least 1 dose of the study drug. Table 5 shows the treatment-emergent adverse events encountered in the astegoid.

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Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. March 13, doi: A motorized IVUS pullback was used to assess coronary atheroma burden at baseline and after 24 months of treatment.

Lipid levels were obtained every 3 months and mean levels during treatment were computed from the time-weighted average of these values.

Treatment to LDL-C levels below currently accepted guidelines, when accompanied by significant HDL-C increases, can regress atherosclerosis in coronary disease patients. The last 2 decades have witnessed the introduction of a variety of antiatherosclerotic therapies, most notably the 3-hydroxymethylglutaryl coenzyme A reductase inhibitors statins. A secondary efficacy parameter, the change in normalized TAV, was calculated by first determining the average atheroma area per cross-section as.

The ASTEROID trial: coronary plaque regression with high-dose statin therapy.

Baseline lipid values for the patients completing the trial and the patients not completing the trial were very closely matched. Using this more conservative end point, only a small study of patients administered an intravenous HDL-C mimetic apolipoprotein A-1 Milano phospholipid has previously shown regression. Sign in to download free article PDFs Sign in to access your subscriptions Sign in to your personal account.

This change represents a median reduction of 6. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: When feasible, clinical outcome trials to assess the effects of therapies on morbidity and mortality always provide more convincing evidence than intermediate end-point studies.