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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He has consulted for a number of pharmaceutical companies without financial compensation. Dr Nissen had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Between November and Octoberpatients had a baseline IVUS examination and received at least 1 dose of study drug.

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

Table 2 summarizes laboratory values obtained during the study for patients completing the trial. Atherosclerosis is generally viewed as a chronic, progressive disease characterized by continuous accumulation of atheromatous plaque within the arterial wall. Selection of Study Patients. Analyses were performed using SAS software, version 8. 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.

After the trial was concluded and all measurements were completed, the sequence coding was unblinded to enable calculation of changes from baseline to follow-up examination. March 13, doi: Effects of AGI and probucol after percutaneous coronary interventions.

Rosuvxstatin atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: Create a free personal account asteroix download free article PDFs, sign up for alerts, customize your interests, and more.

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N Engl J Med. To assess whether very intensive statin therapy could regress coronary atherosclerosis as determined by IVUS imaging. Despite the higher standard of evidence required, the current study demonstrated regression for all 3 prespecified IVUS end points with a high level of statistical significance Table 3. Dr Davignon has received research support and consulting fees from AstraZeneca. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: Purpan University Hospital, Toulouse J.

Baseline lipid values for the patients completing the trial and the patients not completing the trial were very closely matched. 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.

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Designing a contemporary IVUS regression-progression trial creates major challenges that warrant further comment. Of the patients who were not included in the IVUS analysis, 14 were lost to follow-up, 2 were withdrawn per investigator discretion, 3 were withdrawn for protocol violations, 32 patients astrroid consent, 63 were withdrawn for an adverse event, and 11 withdrew for other reasons.

We hypothesized that high-intensity statin therapy, designed to reach very low levels of LDL-C, particularly if achieved in conjunction with substantial elevation of HDL-C, might result in regression of coronary atherosclerosis. Comparison of effects on low-density lipoprotein cholesterol rosuvastatih high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or Roxuvastatin hypercholesterolemia.

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 risuvastatin mm minimum length.

A post hoc sensitivity analysis was performed to assess the potential impact of patients not completing the trial on IVUS measures of efficacy.

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Mss Wolski and Goormastic are employed by the Cleveland Clinic Cardiovascular Coordinating Center, which received compensation for conducting the trial, including reimbursement for statistical services. For the primary efficacy parameter of PAV, A year-old man had an elevated creatine trisl level following an episode of lower back pain that occurred after heavy lifting. The efficacy results are presented as mean and SD and median and interquartile range for the change from baseline.

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.

The statistical analysis plan defined tests of normality for the efficacy parameters and specified nonparametric testing if the data were not normally distributed. Prior well-designed IVUS studies of statin therapy have not yielded compelling evidence for regression.

Subsequently, every 60th image was analyzed, representing cross-sections spaced exactly 1. Statistical analysis was performed by the sponsor and the contract research organization under contract with the sponsor. Purchase access Subscribe to the journal. Patients were examined during scheduled clinic visits every 3 months.

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

For the second primary efficacy parameter, change in the mm subsegment with the greatest disease severity, Demographic and laboratory characteristics were calculated at baseline and follow-up for all patients completing the trial. A safety analysis was performed in all patients who received at least 1 dose of the study drug. Table 4 demonstrates that regression occurred in virtually all subgroups, including men and women, older and younger patients, and most subgroups defined by lipid levels.

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