Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
ACTFAST 2
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.
1 other identifier
interventional
595
8 countries
31
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2003
Shorter than P25 for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedFebruary 18, 2021
February 1, 2021
February 28, 2007
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
Secondary Outcomes (8)
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.
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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
Kecskemét, 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, Ireland
Pfizer Investigational Site
Galway, Ireland
Pfizer Investigational Site
Częstochowa, Poland
Pfizer Investigational Site
Poznan, Poland
Pfizer Investigational Site
Warsaw, Poland
Pfizer Investigational Site
Wroclaw, Poland
Pfizer Investigational Site
Zabrze, Poland
Pfizer Investigational Site
Aveiro, Portugal
Pfizer Investigational Site
Lisbon, Portugal
Pfizer Investigational Site
Porto, Portugal
Pfizer Investigational Site
Vila Franca de Xira, Portugal
Pfizer Investigational Site
Moscow, Russia
Pfizer Investigational Site
Bratislava, Slovakia
Pfizer Investigational Site
Košice, Slovakia
Pfizer Investigational Site
Bern, Switzerland
Pfizer Investigational Site
Geneva, Switzerland
Pfizer Investigational Site
Mendrisio, Switzerland
Pfizer Investigational Site
Zurich, Switzerland
Pfizer Investigational Site
Related Publications (1)
Farsang C, Athyros V, Gaw A; ACTFAST-2 investigators and Steering Committee members. A multicentre, open study to assess the effect of individualizing starting doses of atorvastatin according to baseline LDL-C levels on achieving cholesterol targets: the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST-2) study. Curr Med Res Opin. 2007 Aug;23(8):1945-56. doi: 10.1185/030079907X223242.
PMID: 17626713DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2007
First Posted
March 1, 2007
Study Start
January 1, 2003
Study Completion
February 1, 2004
Last Updated
February 18, 2021
Record last verified: 2021-02