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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However, exploratory analyses imputing less favorable IVUS outcomes for these patients did not alter the conclusions. Because contemporary guidelines and practice patterns require intensive treatment rosuvastayin secondary prevention patients, randomization of patients with established coronary disease to placebo or a low-intensity statin regimen was deemed ethically unacceptable.

Effect of simvastatin on coronary atheroma: March 13, doi: The disposition of these patients is summarized in Figure 1. 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. Monitoring of the study and maintenance of the trial database was performed by a contract research organization, Omnicare, under contract to the sponsor.

Clinic Visits and Laboratory Tests. The paired studies were rosuvastayin randomly resequenced using codes provided by an outside statistician. The current study suggests that there is potential for a more roosuvastatin strategy, in which aggressive lipid-modulating strategies can actually reverse the atherosclerotic disease process. After 24 months, patients had evaluable serial IVUS examinations.

Prior intravascular ultrasound IVUS trials have demonstrated slowing or halting of atherosclerosis progression with statin therapy xsteroid have not shown convincing evidence of regression using percent atheroma volume PAVthe most rigorous IVUS measure of disease progression and regression.

However, none of the major trials has provided convincing evidence of regression using rigorous IVUS measures of disease burden. No large-scale IVUS trials in which patients received statins have demonstrated statistically significant regression. Purchase access Subscribe to the journal. If IVUS data were normally distributed, analysis of covariance, with baseline as a covariate and region as a factor, was specified.

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

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

Moreover, arteries undergoing mechanical interventions were included, which could have affected atheroma measurements. Administrative, technical, or material support: The last 2 decades have witnessed the introduction of a variety of antiatherosclerotic therapies, most notably the 3-hydroxymethylglutaryl coenzyme A reductase inhibitors statins. The current study supports several conclusions.

The very low LDL-C levels and increase in HDL-C levels resulted in significant regression in atheroma burden for all 3 primary and secondary efficacy parameters. All patients were statin-naive, defined as receiving no statin therapy for more than 3 months during the previous 12 months. Personnel who were unaware of the coding and were therefore blinded to the sequence subsequently analyzed both videotapes.

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

For the past 2 decades, clinical trials of antiatherosclerotic ssteroid therapies have sought to reduce coronary disease morbidity and mortality, presumably by decreasing the rate of progression of the underlying atherosclerosis.

Trials using IVUS have successfully investigated the effects of a variety of antiatherosclerotic therapies, including statins, 12161719 blood pressure—lowering drugs, 14 reduction of inflammatory markers, 19 administration of a high-density lipoprotein HDL mimetic, 11 and novel investigative therapies. Change in total atheroma volume showed a 6. This procedure blinded technicians from knowing whether an examination was obtained at baseline or follow-up and thereby eliminated any systematic bias in measurement of paired studies.

Sign in to make a comment Sign in to your tria, account. Multiple muscle biopsies found no evidence of rhabdomyolysis. 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. Of the 3 remaining deaths, 2 were rosuvastaatin to sudden cardiac death and 1 to gastric carcinoma.

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Between November and Octoberpatients were screened and met all inclusion and exclusion criteria, including an acceptable baseline IVUS result, and received study drug at 53 centers. For the primary efficacy parameter of PAV, The mean SD asteroif in atheroma volume in the most diseased mm subsegment was Statistical analysis was performed by the sponsor and the contract research organization under contract with the sponsor. Sign in to eosuvastatin your search Sign in to your personal account.

Although statins rank among the most extensively studied therapies in rosuvvastatin medicine, the optimal target levels for low-density lipoprotein cholesterol LDL-C remain controversial. We recognize the limitations of the current asferoid. Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia.

This procedure was designed to provide the longest possible vessel segment for analysis. Rowuvastatin implicit objective of these therapies is the regression of atherosclerotic plaque, defined as a statistically significant reduction in disease burden. There was roshvastatin significant heterogeneity in the response to treatment for either of the 2 primary efficacy parameters for subgroups defined by age, sex, body mass index, history of diabetes mellitus, LDL-C levels, or HDL-C levels.

In the current trial, each pair of baseline and follow-up IVUS images underwent digital processing to remove date identifiers, performed by technicians not otherwise involved in the study. Otherwise, P values were to be calculated using the Wilcoxon signed rank test. Each pair of baseline and follow-up IVUS assessments was analyzed in a blinded fashion.

The sponsor participated in discussions regarding study design and protocol development and provided logistical support during the trial. If regression of disease is the desired outcome, then lower LDL-C is better.