Shal'nev 2007.
| Methods |
Design: single‐center randomized controlled trial Setting: 1 center in Russia Patient recruitment: unspecified Blinding: none Intention‐to‐treat: unclear Follow‐up period: 6 months Lost to follow‐up: 2 (2%) |
|
| Participants |
Number randomized: statin 55, control 53 Mean age (SD) in years: not available Men, n (%): not available Diabetes, n (%): not available Hypertension, n (%): not available Current smoker, n (%): not available Prior myocardial infarction, n (%): not available Index event, n (%):
Inclusion criteria: patients with acute coronary syndrome (myocardial infarction or unstable angina) |
|
| Interventions | Simvastatin 40 mg/d | |
| Outcomes | Primary: total death, unstable angina (hospitalized and non‐hospitalized), MI (acute and in later follow‐up) | |
| Source | Unspecified | |
| Daily intervention | Unspecified | |
| Control | Usual care | |
| Notes | Outcome data available at 6 months | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generation unspecified |
| Allocation concealment (selection bias) | Unclear risk | Unreported |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding of participants, caregivers, or outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2% of participants lost to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Author contact failed; no study protocol available |
| Other bias | Unclear risk | Adherence to intention‐to‐treat not reported |
ACE: angiotensin‐converting enzyme ACS: acute coronary syndrome AHA: American Heart Association ALT: aminotransferase CABG: coronary artery bypass grafting COPD: chronic obstructive pulmonary disease
CRP: C‐reactive protein d: day ECG: electrocardiogram IL‐6: interleukin‐6 LDL: low‐density lipoprotein
MACE: major adverse cardiac event MI: myocardial infarction
NCEP: National Cholesterol Education Program PCI: percutaneous coronary intervention
UA: unstable angina