RECIFE 1999.

Methods	Design: single‐center randomized controlled trial Setting: 1 center in Canada Patient recruitment: unspecified Blinding: participants and caregivers, but not outcome assessors Intention‐to‐treat: unclear Follow‐up period: 6 weeks Lost to follow‐up: 0 for clinical events
Participants	Number randomized: statin 30, control 30 Mean age (SD) in years: statin 55 (2), control 56 (2) Men, n (%): statin 26 (93%), control 22 (81%) Diabetes, n (%): statin 1 (4%), control 0 (0%) Hypertension, n (%): statin 5 (18%), control 8 (29%) Current smoker, n (%): statin 14 (50%), control 17 (63%) Prior myocardial infarction, n (%): statin 1 (4%), control 2 (7%) Index event, n (%): Myocardial infarction: statin 11 (39%), control 12 (44%) Unstable angina: statin 19 (61%), control 18 (66%) Fibrinolysis therapy: none Percutaneous coronary intervention (PCI): statin 16 (57%), control 17 (63%) Inclusion criteria: diagnosis of acute myocardial infarction or unstable angina and admission total serum cholesterol ?5.2 mmol/L or LDL cholesterol ?3.4 mmol/L and serum triglycerides ?4.5 mmol/L Exclusion criteria: presence of heart failure with an ejection fraction of < 40%, administration of lipid‐lowering agents in the preceding 8 weeks, renal failure with serum creatinine level > 200 mmol/L, and patients requiring coronary artery bypass surgery, premenopausal women, postmenopausal women on hormone replacement therapy
Interventions	Pravastatin 40 mg/d
Outcomes	Primary: brachial artery flow Secondary: composite of death, non‐fatal MI, and non‐fatal stroke, death from any cause, cardiovascular death, fatal MI, non‐fatal MI, total stroke, revascularization procedures (CABG/PCI), unstable angina requiring emergency hospitalization
Source	Funded by Bristol‐Myers Squibb, Canada
Daily intervention	American Heart Association step 2 diet
Control	Placebo
Notes	Outcome data available at 1.5 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	Low risk	Reported blinding of participants and caregivers, but not outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete follow‐up for clinical events
Selective reporting (reporting bias)	Low risk	Author contact established; data on relevant outcomes provided
Other bias	Unclear risk	Adherence to the intention‐to‐treat principle not reported