PACT 2004.

Methods	Design: multi‐center randomized controlled trial Setting: 6 centers in Australia Patient recruitment: unspecified Blinding: patients and caregivers, but not outcome adjudicators Intention‐to‐treat: yes Follow‐up period: 1 month Lost to follow‐up: 85 (2%)
Participants	Number randomized: statin 1710, control 1698 Mean age (SD) in years: statin 62 (12), control 61 (12) Men, n (%): statin 1308 (76%), control 1285 (76%) Diabetes, n (%): statin 244 (14%), control 234 (14%) Hypertension, n (%): statin 700 (41%), control 714 (42%) Current smoker, n (%): statin 608 (36%), control 575 (34%) Prior myocardial infarction, n (%): statin 236 (14%), control 197 (12%) Index event, n (%): Myocardial infarction: statin 1109 (65%), control 1111 (65%) Unstable angina: statin 601 (35%), control 587 (35%) Fibrinolysis therapy: statin 651 (38%), control 671 (40%) Percutaneous coronary intervention (PCI): statin 414 (24%), control 406 (24%) Inclusion criteria: 24 hours of the onset of symptoms if they had electrocardiographic changes suggestive of an acute MI or unstable angina Exclusion criteria: taking statin therapy before their event (other lipid‐lowering therapies were permitted), participation in any other clinical trial or the taking of an investigational drug within the previous 30 days, planned coronary revascularization or cardiac transplantation, severe renal or hepatic disease or other severe disease, drug‐ or alcohol‐related problems, gastrointestinal disease or a history of gastrointestinal surgery that might affect drug absorption, and known hypersensitivity or previous serious adverse reactions to statin therapy Women of child‐bearing potential
Interventions	Pravastatin 20 to 40 mg
Outcomes	Primary: composite of death, non‐fatal MI, and non‐fatal stroke, death from any cause, cardiovascular death, fatal MI, non‐fatal MI, total stroke, unstable angina requiring emergency hospitalization
Source	Bristol‐Myers Squibb, Australia
Daily intervention	Usual care
Control	Placebo
Notes	Outcome data available at 1 month; trial stopped early due to recruitment difficulties
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	2% of participants were lost to follow‐up
Selective reporting (reporting bias)	Low risk	Author contact established; data on relevant outcomes provided
Other bias	Low risk	Adherence to intention‐to‐treat principle; not stopped early for benefit