Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST) (ACTFAST)
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Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)
Condition or disease
Coronary ArteriosclerosisDiabetes Mellitus, Type 2Cerebrovascular AccidentDyslipidemiaPeripheral Vascular Disease
ACTFAST: Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration. A Multicenter, Twelve-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving Low Density Lipoprotein Cholesterol (LDL-C) Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
Secondary Outcome Measures :
Percentage of subjects achieving:
LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata.
LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment.
Change from baseline in apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
Triglycerides up to 600 mg/dL.
History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events
Pregnancy or lactation, use of high statin doses (>40mg) at baseline, liver or renal problems, use of other drugs that would interfere with evaluation of efficacy or cause safety problems, uncontrolled hypertension, diabetes or hypothyroidism, recent cardiac event of procedure, high baseline CPK levels