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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Prior publications have thoroughly described the methods for IVUS interrogation. Sign in to make a comment Sign in to your personal account. However, exploratory analyses imputing less favorable IVUS outcomes for these patients did not alter the conclusions.

One approach imputed all noncompleting patients as showing no change in atheroma burden neither progression nor regression.

We recognize the limitations of the current study. Most atherosclerosis trials have demonstrated that active lipid-modulating therapy, primarily using statin drugs, rosuvastatjn reduce the rate of disease progression. Although statins rank rosufastatin the most extensively studied therapies in contemporary medicine, the optimal target levels for low-density lipoprotein cholesterol LDL-C remain controversial.

This change represents a median reduction of 9. A motorized pullback was repeated under conditions identical rosuvastarin the baseline study. The institutional review boards of all participating centers approved the protocol and all rosuvasstatin provided written informed consent.

Statistical analysis was performed by the sponsor and the contract research organization under contract with the sponsor. The efficacy results are presented as mean and SD and median and interquartile range for the change from baseline. 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.


For the second primary efficacy parameter, change in the mm subsegment with the greatest disease severity, Role of the Sponsor: An implicit objective of these therapies is the regression of atherosclerotic plaque, defined as a statistically significant reduction in disease burden.

The characteristics of the noncompleters were very similar to those of the completers in terms of age, sex, weight, body mass index calculated as weight in kilograms divided by the square of height in metersand prevalence of hypertension and diabetes. Nissen, Nicholls, Schoenhagen, Crowe, Tuzcu. These changes were larger in triall than has been observed in previous statin trials. 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.

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A motorized IVUS pullback was used to assess coronary atheroma burden at baseline and after 24 months of treatment.

For patients without 10 contiguous evaluable cross-sections, 8 or 9 cross-sections were used and the results were normalized to compensate for the missing cross-sections. N Engl J Med. A motorized IVUS pullback was used to assess coronary atheroma burden at baseline and after 24 rosuvawtatin of treatment.

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

These statisticians received the trial database simultaneously with the sponsor, which included all raw data, not just derived rosugastatin sets, and independently computed the IVUS efficacy parameters and confirmed the lipid level outcomes and basic demographic variables.

Analyses were performed using SAS software, version 8. Videotapes containing baseline and follow-up pullbacks were analyzed in the Intravascular Ultrasound Core Laboratory at the Cleveland Clinic Foundation.


Demographic and laboratory characteristics were calculated at baseline and follow-up for all patients completing the trial. Clinical trials of combination therapies designed to both lower LDL-C and raise HDL-C using novel antiatherosclerotic therapies are currently under way and will report results within the next 18 months.

Recently, several active control trials have reported that more intensive statin therapy results in a greater reduction in adverse cardiovascular outcomes compared with more moderate treatment. Effect of simvastatin on coronary atheroma: Nat Clin Pract Cardiovasc Med. Multiple muscle biopsies eosuvastatin no evidence of rhabdomyolysis. Regression was achieved by reducing LDL-C levels to a trila of In the current study, the choice of 2 primary efficacy parameters allowed testing of drug effects on regression using hrial different standards of evidence.

Moreover, arteries undergoing mechanical interventions were included, which could have affected atheroma measurements.

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

Selection of Study Patients. These observations support the recommendation to administer very intensive statin therapy for high-risk patients with established coronary disease. The paired studies were then randomly resequenced using codes provided by an outside statistician.

Administrative, technical, or material support: Raichlen, MD ; Christie M. This procedure was designed to provide the longest possible vessel segment for analysis.

Unfortunately, the goal of inducing actual regression of atherosclerosis has remained elusive.