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. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

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
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Withdrawn (N): intervention: 0; control:0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.
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
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.