PTT 2002.
Methods |
Design: single‐center randomized controlled trial Setting: 1 center in Turkey Patient recruitment: June 1997 to September 1998 Blinding: none Intention‐to‐treat: unclear Follow‐up period: 6 months Lost to follow‐up: 0 |
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Participants |
Number randomized: statin 79, control 85 Mean age (SD) in years: statin 53 (11), control 52 (10) Men, n (%): statin 65 (82%), control 69 (81%) Diabetes, n (%): statin 14 (18%), control 13 (15%) Hypertension, n (%): statin 16 (20%), control 21 (25%) Current smoker, n (%): statin 63 (80%), control 66 (78%) Prior myocardial infarction, n (%): statin none, control none Index event, n (%):
Inclusion criteria: patients receiving fibrinolysis therapy within 6 hours of ST‐segment elevated acute MI Exclusion criteria: contraindications for thrombolytic therapy, age > 75 years, history of myocardial infarction, previous percutaneous transluminal coronary angioplasty, coronary artery bypass graft surgery, congestive heart failure, secondary hyperlipidemia, uncontrolled hypertension or diabetes mellitus, liver disease, thyroid dysfunction, use of anticoagulant drugs other than aspirin, use of steroids or hormone replacement therapy, women of childbearing potential and patients with physical or psychosocial disorders that could interfere with protocol adherence |
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Interventions | Pravastatin 40 mg/d | |
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), "recurrent angina pectoris" | |
Source | Not funded | |
Daily intervention | All patients received fibrinolysis therapy, intravenous nitrates, heparin infusions, a AHA step II diet and a daily 100 mg aspirin | |
Control | Usual care | |
Notes | Outcome data available at 1 and 6 months. Note: only a subgroup of 77 patients (40 intervention, 37 control, those who received additional coronary angioplasty) were followed up for 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 clinical outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up for clinical outcomes |
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 |