Kodali 2011.
Methods |
Design: RCT Number of study centres: not reported, USA Setting: not reported Patient recruitment: not reported Duration of study (Follow‐up): 12 months Clinical setting: 'statin naive' patients with maximum carotid stenosis > 50% |
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Participants |
Enrolment (N): 18 Randomised (N): not reported Withdrawn (N): not reported Lost to follow‐up (N): not reported Completed the study (N): not reported Analysed (N): not reported Age (years) (mean ± SD): not reported Sex (male, N, %): not reported Smoking history (N, %): not reported BMI (kg/m², mean ± SD):): not reported Diabetes (N, %): not reported Hypertension (N, %): not reported History of CHD (N, %): not reported Statin pretreatment (N, %): intervention:0% ; control:0% Inclusion criteria: 'statin naive' patients with maximum carotid stenosis > 50% Exclusion criteria: not reported |
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Interventions |
Intervention: ezetimibe 10 mg/ simvastatin 40 mg Comparison: simvastatin 40 mg Details of any 'run‐in' period: not reported Concomitant medications: not reported Excluded medications: not reported |
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Outcomes | Primary: changes in carotid outer wall area (OWA), lumen area (LA), vessel wall area (VWA), lipid area (LpA) and lipid percentage (Lp%), measured by high‐resolution CMR | |
Notes | Two conference abstracts only. No outcome data relevant to this review. Emailed trialists for details. No response Source of funding: not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized", but no further details. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | High risk | Published conference abstract only |