Ren 2017.
Methods |
Design: RCT Number of study centres: single centre in China Setting: inpatient and outpatient Patient recruitment: January 2015 to June 2016 Duration of study (Follow‐up):12 months Clinical setting: acute MI |
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Participants |
Enrolment (N): 135 Randomised (N): intervention:55 ; control:58 Withdrawn (N): intervention: 0; control:0 Lost to follow‐up (N): intervention: 0; control:0 Completed the study (N): intervention:55 ; control:58 Analysed (N): intervention: 55; control:58 Age (years) (mean ± SD): intervention: 57.3 ± 1.5; control: 60.7 ± 1.3 Sex (male, N, %): intervention:46(79.3%); control: 48(87.3%) Smoking history (N, %): intervention:38 (65.5%) ; control:39 (70.9%) BMI (kg/m², mean ± SD):): not reported Diabetes (N, %): intervention: 10(17.2%); control:10(18.2%) Hypertension (N, %): intervention: 35 (60.3%); control:31 (56.4)% History of MI (N, %): intervention: 1(1.7%); control:2(3.6%) Statin pretreatment (N, %): intervention: 6 (10.5%); control:5 (9.1%) Inclusion criteria: Quote: "patients aged within the range of 18 to 80 years were eligible if hospitalized within the preceding 24 h for acute myocardial infarction, including ST‐segment elevation myocardial infarction (STEMI) with or without ST‐segment elevation myocardial infarction (NSTEMI)." Exclusion criteria: i) Contraindications for the intervention; ii) statin use was contraindicated, for example, due to the patient having active hepatitis or being allergic to statins; iii) severe cardiac dysfunction (Killip class III or IV); iv) severe renal insufficiency; and v) other comorbidities, including infection, systemic immune diseases, pericarditis and malicious tumour. |
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Interventions |
Intervention: ezetimibe (10 mg) plus rosuvastatin (10 mg) Comparison: rosuvastatin (10 mg) Details of any 'run‐in' period: Quote: "Following 1 week of the intervention, 113 patients continued to meet the inclusion criteria and were randomly divided into two groups” Concomitant medications: not reported Excluded medications: not reported |
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Outcomes | Primary: lipid level, inflammatory markers (high‐sensitivity CRP and lipoprotein associated phospholipase A2) at 1, 3 and 12months. | |
Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by means of a computer‐generated sequence of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Double‐blind (participant,iInvestigator, outcomes' assessor) |
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 | Low risk | All the patients completed the study. |
Selective reporting (reporting bias) | Unclear risk | No protocol published, or trials registry record found. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |