FLORIDA 2002.
| Methods |
Design: multi‐center randomized controlled trial Setting: 28 centers in The Netherlands Patient recruitment: July 1997 to May 1999 Blinding: patients, caregivers, and outcome adjudicators Intention‐to‐treat: unspecified Follow‐up period: 12 months Lost to follow‐up: 0 |
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| Participants |
Number randomized: statin 265, control 275 Mean age (SD) in years: statin 61 (12), control 60 (11) Men, n (%): statin 214 (81%), control 234 (85%) Diabetes, n (%): statin 29 (11%), control 31 (11%) Hypertension, n (%): statin 67 (25%), control 65 (24%) Current smoker, n (%): statin 140 (53%), control 139 (51%) Prior myocardial infarction, n (%): statin 31 (12%), control 31 (11%) Index event, n (%):
Inclusion criteria: new or markedly increased chest pain lasting longer than 30 minutes, or a new pathological Q wave of 0.04 s duration, or 25% of the corresponding R wave amplitude, both in at least 2 contiguous leads Exclusion criteria: age < 18 years, use of lipid‐lowering agents within the previous 3 months, a high triglyceride level of > 4.5 mmol/l, known familial dyslipidemia, severe renal failure, known hepatic disease, signs and symptoms of severe heart failure (New York Heart Association class IV), a scheduled percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) and co‐medication that influences the ST‐segment (digoxin, quinidine or tricyclic antidepressants), atrial fibrillation, Wolff‐Parkinson‐White syndrome, complete left bundle‐branch block, known pre‐existent ST‐segment deviations before the qualifying MI, left ventricular hypertrophy with a pattern of strain or presence of a permanent pacemaker |
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| Interventions | Fluvastatin 80 mg within 14 days of ACS | |
| 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, revascularization procedures (CABG/PCI), unstable angina requiring emergency hospitalization Secondary: ischemia on the ambulatory ECG (without taking clinical events into account), change in ischemic burden, the time to a major clinical event and the 12‐month change in lipid profile |
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| Source | Unrestricted Grant from AstraZeneca, The Netherlands | |
| Daily intervention | At discretion of attending cardiologist for starting standard medication including aspirin, beta‐blocking agents, and/or ACE‐inhibitors | |
| Control | Placebo | |
| Notes | Outcome data available at 1, 4, 6, and 12 months | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomization sequence generation unspecified |
| Allocation concealment (selection bias) | Unclear risk | Unreported |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Reported blinding of participants, caregivers, and outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete patient follow‐up |
| Selective reporting (reporting bias) | Low risk | Author contact established; data on relevant outcomes provided |
| Other bias | Unclear risk | Adherence to intention‐to‐treat principle not reported |