Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442325
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : October 25, 2007
Information provided by:

Brief Summary:
European 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 Intervention/treatment Phase
Coronary Arteriosclerosis Diabetes Mellitus, Type 2 Cerebrovascular Accident Dyslipidemia Peripheral Vascular Disease Drug: Atorvastatin (Lipitor) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 595 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACTFAST (2): 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 : January 2003
Study Completion Date : February 2004

Primary Outcome Measures :
  1. Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.

Secondary Outcome Measures :
  1. Percentage of subjects achieving:
  2. LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
  3. Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
  4. 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.
  5. 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.
  6. 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.
  7. LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
  8. 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 apol

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442325

Pfizer Investigational Site
Ioannina, Greece
Pfizer Investigational Site
Kallithea, Athens, Greece
Pfizer Investigational Site
Pireaus, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Pfizer Investigational Site
Budapest, Hungary
Pfizer Investigational Site
Gyula, Hungary
Pfizer Investigational Site
Kecskemet, Hungary
Pfizer Investigational Site
Nyíregyháza, Hungary
Pfizer Investigational Site
Szekszárd, Hungary
Pfizer Investigational Site
Tullamore, Co. Offlay, Ireland
Pfizer Investigational Site
Tallaght, Dublin, Ireland
Pfizer Investigational Site
Gorey, Wexford, Ireland
Pfizer Investigational Site
Cork, Ireland
Pfizer Investigational Site
Dublin 8, Ireland
Pfizer Investigational Site
Dublin, Ireland
Pfizer Investigational Site
Galway, Ireland
Pfizer Investigational Site
Czestochowa, Poland
Pfizer Investigational Site
Poznan, Poland
Pfizer Investigational Site
Warszawa, Poland
Pfizer Investigational Site
Wroclaw, Poland
Pfizer Investigational Site
Zabrze, Poland
Pfizer Investigational Site
Aveiro, Portugal
Pfizer Investigational Site
Lisboa, Portugal
Pfizer Investigational Site
Porto, Portugal
Pfizer Investigational Site
Vila Franca de Xira, Portugal
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation
Pfizer Investigational Site
Bratislava, Slovakia
Pfizer Investigational Site
Kosice, Slovakia
Pfizer Investigational Site
Bern, Switzerland
Pfizer Investigational Site
Genève, Switzerland
Pfizer Investigational Site
Mendrisio, Switzerland
Pfizer Investigational Site
Zürich, Switzerland
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00442325     History of Changes
Other Study ID Numbers: A2581095
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Brain Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Coronary Artery Disease
Myocardial Ischemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Cardiovascular Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors