Kim 2004.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 129 adults and elderly (macrolide n = 64, placebo n = 65) Age in years (mean ± SD): macrolide: 60.0 ± 10.0, placebo: 59.6 ± 10.1 Setting: secondary care |
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Interventions |
Indication: acute coronary syndrome who underwent PCI Type of macrolide: azithromycin Route: per oral Dose: 500 mg daily for 3 days before and after PCI, followed by 500 mg/week Duration of treatment: 3 weeks Total treatment dose: 4000 mg |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: unclear Adverse events ascertainment: clinical examination (lab tests) Adverse events: incomplete reporting, author contacted Antimicrobial resistance: not reported Death: data reported |
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Funding sources | Not stated | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear if matching placebo used. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No adverse events reported, death is an objective outcome. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12 months follow‐up in 95% of participants. |
Selective reporting (reporting bias) | High risk | Adverse events not stated clearly as an outcome, unclear ascertainment, adverse events not reported (only adverse cardiac outcomes are reported on). |
Other bias | Low risk | None were identified. |