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. 2014 Sep 1;2014(9):CD006870. doi: 10.1002/14651858.CD006870.pub3

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
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 (%):
  • Myocardial infarction: statin 79 (100%), control 85 (100%)

  • Unstable angina: none

  • Fibrinolysis therapy: statin 79 (100%), control 85 (100%)

  • Percutaneous coronary intervention (PCI): none


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
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