EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).

Rosuvastatin in the long-term treatment of hypercholesterolaemic subjects with coronary heart disease

Research Site

A study to evaluate the efficacy and safety of rosuvastatin in the long-term treatment of hypercholesterolaemic subjects with coronary heart disease as measured by intravascular ultrasonography

Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.

Age Continuous

1 participant did not receive drug and is not captured in these figures

Gender, Male/Female

Because there was no placebo arm the net effect of rosuvastatin was not clarified. This study examined only single measurable plaques, which might not represent pan-coronary nature of plaque.

Percent change from baseline (before the start of rosuvastatin treatment) to Week 76 in the plaque volume (PV)

Target Lesion indicates Coronary plaque composition of culprit lesions.

Change from baseline to Week 76 in plaque volume (PV) in the target lesion

Percent change from baseline to specified measurement time points in low-density lipoprotein （LDL-C）

Percent Change in high-sensitivity C-reactive protein (HS-CRP) from baseline to specified measurement time points

Overall Study

Observation Period :Prior to study-related activities, all subjects will sign an informed consent form. IVUS and CAG is performed prior Treatment
Treatment Period: Eligible patients started treatment; rosuvastatin 2.5 mg once daily; those whose LDL-C remained >80 mg/dl after 4 wks of treatment, the dose can be titrated to a maximum of 20 mg/day

Rosuvastatin in the long-term treatment of hypercholesterolaemic subjects with coronary heart disease

Official Title

Medical condition

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Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

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Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=324&filename=CSR-D3565L00002.pdf

CSR-D3565L00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator